Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355) (NCT NCT02819518)

NCT ID: NCT02819518

Last Updated: 2024-11-27

Results Overview

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 882 participants
• Primary outcome timeframe: Up to approximately 39 months
• Results posted on: 2024-11-27

Participant Flow

35 participants were randomized to Part 1 (Safety Run-in) of the study, and 847 participants were randomized in Part 2 (phase 3) of the study. 12 participants randomized to the Part 2: Pembrolizumab + Chemotherapy arm received a second course of pembrolizumab at the investigator's discretion. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures respectively.

Participant milestones

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.	Part 2: Pembrolizumab + Chemotherapy Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).	Part 2: Placebo + Chemotherapy Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle
Overall Study STARTED	11	14	10	566	281
Overall Study Treated	13	10	11	562	281
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	11	14	10	566	281

Reasons for withdrawal

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.	Part 2: Pembrolizumab + Chemotherapy Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).	Part 2: Placebo + Chemotherapy Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle
Overall Study Death	9	12	9	475	244
Overall Study Withdrawal by Subject	0	0	0	25	8
Overall Study Lost to Follow-up	0	0	0	0	1
Overall Study Sponsor Decision	1	1	0	34	17
Overall Study Transferred to extension study	1	1	1	32	11

Baseline Characteristics

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

Baseline characteristics by cohort

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=11 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=14 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin n=10 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.	Part 2: Pembrolizumab + Chemotherapy n=566 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).	Part 2: Placebo + Chemotherapy n=281 Participants Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.	Total n=882 Participants Total of all reporting groups
Age, Continuous	54.6 Years STANDARD_DEVIATION 13.5 • n=5 Participants	60.4 Years STANDARD_DEVIATION 15.3 • n=7 Participants	59.6 Years STANDARD_DEVIATION 11.7 • n=5 Participants	53.5 Years STANDARD_DEVIATION 12.7 • n=4 Participants	53.0 Years STANDARD_DEVIATION 12.7 • n=21 Participants	53.5 Years STANDARD_DEVIATION 12.8 • n=8 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	566 Participants n=4 Participants	281 Participants n=21 Participants	882 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	116 Participants n=4 Participants	48 Participants n=21 Participants	165 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	423 Participants n=4 Participants	218 Participants n=21 Participants	674 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	27 Participants n=4 Participants	15 Participants n=21 Participants	43 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants	1 Participants n=21 Participants	12 Participants n=8 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	123 Participants n=4 Participants	52 Participants n=21 Participants	190 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	20 Participants n=4 Participants	17 Participants n=21 Participants	38 Participants n=8 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	384 Participants n=4 Participants	195 Participants n=21 Participants	598 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants	8 Participants n=21 Participants	19 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants	8 Participants n=21 Participants	25 Participants n=8 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status (Combined Positive Score [CPS] Cutoff of 1) PD-L1 CPS ≥1	8 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	425 Participants n=4 Participants	211 Participants n=21 Participants	663 Participants n=8 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status (Combined Positive Score [CPS] Cutoff of 1) PD-L1 CPS <1	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	141 Participants n=4 Participants	70 Participants n=21 Participants	219 Participants n=8 Participants
PD-L1 Status (CPS Cutoff of 10) PD-L1 CPS ≥10	1 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	220 Participants n=4 Participants	103 Participants n=21 Participants	337 Participants n=8 Participants
PD-L1 Status (CPS Cutoff of 10) PD-L1 CPS <10	10 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	346 Participants n=4 Participants	178 Participants n=21 Participants	545 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to approximately 39 months

Population: All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=13 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=10 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin n=11 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants	100.0 Percentage of Participants	100.0 Percentage of Participants	100.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to approximately 39 months

Population: All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=13 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=10 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin n=11 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants	38.5 Percentage of Participants	50.0 Percentage of Participants	27.3 Percentage of Participants

PRIMARY outcome

Timeframe: Up to approximately 53 months

Population: Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs 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. The appearance of one or more new lesions was also considered PD.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=566 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=281 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Progression-Free Survival (PFS) - All Participants	7.5 Months Interval 6.3 to 7.7	5.6 Months Interval 5.4 to 7.2	—

PRIMARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs 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. The appearance of one or more new lesions was also considered PD.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=425 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=211 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors	7.6 Months Interval 6.6 to 8.0	5.6 Months Interval 5.4 to 7.4	—

PRIMARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs 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. The appearance of one or more new lesions was also considered PD.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=220 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=103 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors	9.7 Months Interval 7.6 to 11.3	5.6 Months Interval 5.3 to 7.5	—

PRIMARY outcome

Timeframe: Up to approximately 53 months

Population: Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=566 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=281 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Overall Survival (OS) - All Participants	17.2 Months Interval 15.3 to 19.0	15.5 Months Interval 13.9 to 17.2	—

PRIMARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=425 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=211 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors	17.6 Months Interval 15.5 to 19.5	16.0 Months Interval 12.8 to 17.4	—

PRIMARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=220 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=103 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors	23.0 Months Interval 19.0 to 26.3	16.1 Months Interval 12.6 to 18.8	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=566 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=281 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Objective Response Rate (ORR) - All Participants	40.8 Percentage of Participants Interval 36.7 to 45.0	37.0 Percentage of Participants Interval 31.4 to 42.9	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=425 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=211 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors	44.9 Percentage of Participants Interval 40.1 to 49.8	38.9 Percentage of Participants Interval 32.2 to 45.8	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=220 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=103 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: ORR - Participants With PD-L1 CPS ≥10 Tumors	52.7 Percentage of Participants Interval 45.9 to 59.5	40.8 Percentage of Participants Interval 31.2 to 50.9	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: All randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.

For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=231 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=104 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Duration of Response (DOR) - All Participants	NA Months NA indicates median, upper limit, lower limit not reached due to insufficient number of responding participants with relapse	6.5 Months Interval 1.5 to NA indicates upper limit not reached due to insufficient number of responding participants with relapse	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: All randomized participants with PD-LI CPS ≥1 tumors regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.

For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=191 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=82 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: DOR - Participants With PD-L1 CPS ≥1 Tumors	NA Months NA indicates median, upper limit, lower limit not reached due to insufficient number of responding participants with relapse	6.8 Months Interval 1.5 to NA indicates upper limit not reached due to insufficient number of responding participants with relapse	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: All randomized participants with PD-LI CPS ≥10 tumors regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.

For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=116 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=42 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: DOR - Participants With PD-L1 CPS ≥10 Tumors	NA Months NA indicates median, upper limit, lower limit not reached due to insufficient number of responding participants with relapse	7.3 Months Interval 1.5 to NA indicates upper limit not reached due to insufficient number of responding participants with relapse	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=566 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=281 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Disease Control Rate (DCR) - All Participants	56.0 Percentage of Participants Interval 51.8 to 60.1	51.2 Percentage of Participants Interval 45.2 to 57.2	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥1 tumors at baseline were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=425 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=211 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: DCR - Participants With PD-L1 CPS ≥1 Tumors	58.6 Percentage of Participants Interval 53.7 to 63.3	53.6 Percentage of Participants Interval 46.6 to 60.4	—

SECONDARY outcome

Timeframe: Up to approximately 53 months

Population: Participants with PD-L1 CPS ≥10 tumors at baseline were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=220 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=103 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: DCR - Participants With PD-L1 CPS ≥10 Tumors	65.0 Percentage of Participants Interval 58.3 to 71.3	54.4 Percentage of Participants Interval 44.3 to 64.2	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: All randomized participants who received at least 1 dose of study intervention. Participants were included in the group corresponding to the study intervention actually received.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=562 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=281 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Percentage of Participants Who Experienced an AE- All Participants	98.6 Percentage of Participants	98.2 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to approximately 81 months

Population: All randomized participants who received at least 1 dose of study intervention. Participants were included in the group corresponding to the study intervention actually received.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=562 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=281 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Percentage of Participants Who Discontinued Study Drug Due to an AE- All Participants	20.5 Percentage of Participants	13.2 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 15

Population: All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=554 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=278 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants	-3.52 Scores on a scale Interval -5.61 to -1.42	-2.15 Scores on a scale Interval -4.97 to 0.67	—

SECONDARY outcome

Timeframe: Baseline and Week 15

Population: All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=415 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=208 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors	-3.92 Scores on a scale Interval -6.42 to -1.44	-3.15 Scores on a scale Interval -6.54 to 0.24	—

SECONDARY outcome

Timeframe: Baseline and Week 15

Population: All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=216 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=100 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors	-2.69 Scores on a scale Interval -5.86 to 0.48	-0.88 Scores on a scale Interval -5.41 to 3.64	—

SECONDARY outcome

Timeframe: Baseline and Week 15

Population: All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=554 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=278 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants	12.50 Scores on a scale Interval 10.84 to 14.15	12.36 Scores on a scale Interval 10.06 to 14.65	—

SECONDARY outcome

Timeframe: Baseline and Week 15

Population: All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=415 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=208 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors	13.00 Scores on a scale Interval 11.08 to 14.91	11.86 Scores on a scale Interval 9.17 to 14.55	—

SECONDARY outcome

Timeframe: Baseline and Week 15

Population: All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.

Outcome measures

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=216 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=100 Participants Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors	13.56 Scores on a scale Interval 10.88 to 16.23	13.26 Scores on a scale Interval 9.28 to 17.25	—

Adverse Events

Part 1: Pembrolizumab + Nab-Paclitaxel

Serious events: 3 serious events

Other events: 13 other events

Deaths: 9 deaths

Part 1: Pembrolizumab + Paclitaxel

Serious events: 4 serious events

Other events: 10 other events

Deaths: 12 deaths

Part 1: Pembrolizumab + Gemcitabine/Carboplatin

Serious events: 9 serious events

Other events: 11 other events

Deaths: 9 deaths

Part 2: Pembrolizumab + Chemotherapy (First Course)

Serious events: 169 serious events

Other events: 551 other events

Deaths: 484 deaths

Part 2: Pembrolizumab + Chemotherapy (Second Course)

Serious events: 3 serious events

Other events: 11 other events

Deaths: 5 deaths

Part 2: Placebo + Chemotherapy

Serious events: 68 serious events

Other events: 273 other events

Deaths: 249 deaths

Serious adverse events

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=13 participants at risk Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=10 participants at risk Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin n=11 participants at risk Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.	Part 2: Pembrolizumab + Chemotherapy (First Course) n=562 participants at risk Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).	Part 2: Pembrolizumab + Chemotherapy (Second Course) n=12 participants at risk Eligible participants received up to 17 additional administrations (up to approximately 1year) of pembrolizumab 200 mg IV on day 1 of each 21-day cycle.	Part 2: Placebo + Chemotherapy n=281 participants at risk Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Leukopenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Lymphopenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Myelosuppression	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Neutropenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Pancytopenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Acute myocardial infarction	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Arrhythmia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Atrial fibrillation	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Cardiac arrest	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Cardiac failure	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Cardiac failure congestive	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Cardio-respiratory arrest	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Cardiopulmonary failure	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Myocarditis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Sinus bradycardia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Adrenal insufficiency	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Hypothyroidism	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Pyrexia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Non-cardiac chest pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Oedema peripheral	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Papilloedema	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Cheilitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Colitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Dysphagia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Food poisoning	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Gastritis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Haematemesis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Intestinal obstruction	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Nausea	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Pancreatitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Stomatitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Vomiting	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 10/562 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Asthenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Chest pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Death	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Drug withdrawal syndrome	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Face oedema	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Fat necrosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Fatigue	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Malaise	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Multiple organ dysfunction syndrome	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Cholelithiasis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Hepatitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Hepatotoxicity	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Liver disorder	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Steatohepatitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Immune system disorders Anaphylactic reaction	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Abdominal abscess	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Abscess	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Bacteraemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Biliary tract infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Breast cellulitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations COVID-19	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Cellulitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Cystitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Device related infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Device related sepsis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Endocarditis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Gastroenteritis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Herpes zoster	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Influenza	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Lower respiratory tract infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Mastitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Meningitis aseptic	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Nasopharyngitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Neutropenic sepsis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pneumonia	15.4% 2/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.5% 7/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pneumonia aspiration	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pneumonia bacterial	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pneumonia mycoplasmal	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pneumonia staphylococcal	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pneumonia streptococcal	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pseudomonal sepsis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pulmonary sepsis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pyelonephritis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Respiratory tract infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Sepsis	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Septic shock	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Skin infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Soft tissue infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Staphylococcal infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Staphylococcal sepsis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Streptococcal sepsis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Superinfection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Upper respiratory tract infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Urinary tract infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Urosepsis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Vascular device infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Viral infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Contusion	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Limb injury	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Radius fracture	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Rib fracture	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Transfusion-related acute lung injury	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Alanine aminotransferase increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Aspartate aminotransferase increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood corticotrophin increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood creatinine increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Cortisol decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Hepatic enzyme increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Liver function test abnormal	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Neutrophil count decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Pancreatic enzymes increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Platelet count decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Transaminases increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Decreased appetite	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Bone pain	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Brain oedema	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Cerebellar haemorrhage	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Cerebral haematoma	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Cerebral venous sinus thrombosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Cerebrovascular accident	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Guillain-Barre syndrome	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Haemorrhagic stroke	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Headache	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Hepatic encephalopathy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Intracranial pressure increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Myelopathy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Parkinsonism	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Peripheral motor neuropathy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Syncope	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Transient ischaemic attack	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Product Issues Device dislocation	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Anxiety	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Confusional state	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Acute kidney injury	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Hydronephrosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Kidney enlargement	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Nephritis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Renal failure	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Urinary retention	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Urinary tract obstruction	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Reproductive system and breast disorders Breast pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Drug eruption	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Surgical and medical procedures Assisted suicide	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Deep vein thrombosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Embolism	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Hypertension	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Hypertensive emergency	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Hypotension	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Shock haemorrhagic	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Thrombosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Varicose vein	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Venous thrombosis limb	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..

Other adverse events

Measure	Part 1: Pembrolizumab + Nab-Paclitaxel n=13 participants at risk Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Paclitaxel n=10 participants at risk Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.	Part 1: Pembrolizumab + Gemcitabine/Carboplatin n=11 participants at risk Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.	Part 2: Pembrolizumab + Chemotherapy (First Course) n=562 participants at risk Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).	Part 2: Pembrolizumab + Chemotherapy (Second Course) n=12 participants at risk Eligible participants received up to 17 additional administrations (up to approximately 1year) of pembrolizumab 200 mg IV on day 1 of each 21-day cycle.	Part 2: Placebo + Chemotherapy n=281 participants at risk Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle
Eye disorders Diplopia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 5/281 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Dry eye	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 20/562 • Number of events 20 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 8/281 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Anaemia	38.5% 5/13 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	50.0% 5/10 • Number of events 15 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	72.7% 8/11 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	52.3% 294/562 • Number of events 633 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	33.3% 4/12 • Number of events 22 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	49.8% 140/281 • Number of events 258 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Leukopenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 64 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.8% 111/562 • Number of events 461 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	17.8% 50/281 • Number of events 158 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Lymphopenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.3% 30/562 • Number of events 62 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 15 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Neutropenia	15.4% 2/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 21 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	63.6% 7/11 • Number of events 90 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	41.3% 232/562 • Number of events 936 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.7% 2/12 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	38.8% 109/281 • Number of events 384 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	45.5% 5/11 • Number of events 89 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.6% 110/562 • Number of events 346 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.9% 56/281 • Number of events 155 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Cardiac disorders Tachycardia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 8/562 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Ear and labyrinth disorders Vertigo	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 20/562 • Number of events 22 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.3% 12/281 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Adrenal insufficiency	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Hyperthyroidism	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.4% 25/562 • Number of events 25 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Hypophysitis	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Hypothyroidism	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	36.4% 4/11 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	15.1% 85/562 • Number of events 96 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.2% 9/281 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Endocrine disorders Thyroiditis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Eye pain	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Eye pruritus	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Eye swelling	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Eyelid cyst	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Ocular discomfort	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Eye disorders Vision blurred	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.6% 9/562 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 8/281 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Abdominal discomfort	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Abdominal distension	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.3% 3/11 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	7.7% 43/562 • Number of events 57 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.9% 25/281 • Number of events 28 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.0% 45/562 • Number of events 64 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.7% 16/281 • Number of events 19 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Anal fissure	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Colitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 8/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Constipation	23.1% 3/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	54.5% 6/11 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.6% 155/562 • Number of events 212 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.4% 77/281 • Number of events 97 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Dental caries	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Diarrhoea	38.5% 5/13 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	54.5% 6/11 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.6% 155/562 • Number of events 305 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	23.5% 66/281 • Number of events 134 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 22/562 • Number of events 23 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 10/281 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	6.8% 38/562 • Number of events 45 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.7% 16/281 • Number of events 19 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Flatulence	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Gastritis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.2% 18/562 • Number of events 18 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.5% 7/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.7% 15/562 • Number of events 16 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 11/281 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Gingival bleeding	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Nausea	46.2% 6/13 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	36.4% 4/11 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	44.7% 251/562 • Number of events 522 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	46.3% 130/281 • Number of events 254 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Stomatitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.6% 54/562 • Number of events 76 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	6.8% 19/281 • Number of events 22 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Gastrointestinal disorders Vomiting	23.1% 3/13 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	54.5% 6/11 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	24.9% 140/562 • Number of events 248 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	22.1% 62/281 • Number of events 107 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Asthenia	46.2% 6/13 • Number of events 16 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.3% 3/11 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.2% 108/562 • Number of events 194 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.7% 47/281 • Number of events 84 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Chest pain	15.4% 2/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.4% 25/562 • Number of events 27 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	6.0% 17/281 • Number of events 20 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Chills	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 16/562 • Number of events 18 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.5% 7/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Fatigue	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	32.0% 180/562 • Number of events 258 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	34.2% 96/281 • Number of events 119 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Infusion site extravasation	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Infusion site pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Injection site reaction	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Malaise	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.4% 25/562 • Number of events 38 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.0% 14/281 • Number of events 25 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Mucosal dryness	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Mucosal inflammation	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.5% 31/562 • Number of events 41 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.0% 14/281 • Number of events 21 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Oedema	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Oedema peripheral	38.5% 5/13 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	11.6% 65/562 • Number of events 83 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.3% 29/281 • Number of events 42 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Pyrexia	23.1% 3/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	17.6% 99/562 • Number of events 150 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.7% 2/12 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.6% 55/281 • Number of events 85 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
General disorders Thirst	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Hepatobiliary disorders Hypertransaminasaemia	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Immune system disorders Contrast media allergy	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Immune system disorders Drug hypersensitivity	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Immune system disorders Hypersensitivity	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 8/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 8/281 • Number of events 16 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Appendicitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations COVID-19	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Cellulitis	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.6% 9/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Conjunctivitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Conjunctivitis viral	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Cystitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Erythema infectiosum	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Gastroenteritis	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 8/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 5/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Gastrointestinal infection	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Hordeolum	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Influenza	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.0% 28/562 • Number of events 30 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 8/281 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Lip infection	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Nasopharyngitis	23.1% 3/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.4% 53/562 • Number of events 76 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	7.5% 21/281 • Number of events 28 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Oral candidiasis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Oropharyngeal candidiasis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Pharyngitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 8/562 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 5/281 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Rash pustular	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Rhinitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Skin infection	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Tonsillitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 8/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Upper respiratory tract infection	38.5% 5/13 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.3% 58/562 • Number of events 94 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.3% 26/281 • Number of events 36 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.7% 49/562 • Number of events 70 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.6% 13/281 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Viral diarrhoea	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Viral infection	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.6% 9/562 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Viral upper respiratory tract infection	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Infections and infestations Vulvovaginitis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Animal bite	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Contusion	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.6% 9/562 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Fracture	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Incision site pain	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Limb injury	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Thermal burn	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Injury, poisoning and procedural complications Wound complication	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Activated partial thromboplastin time prolonged	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Alanine aminotransferase increased	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 28 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	24.7% 139/562 • Number of events 242 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.7% 2/12 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.6% 55/281 • Number of events 84 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Amylase increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 17 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	23.3% 131/562 • Number of events 225 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.4% 46/281 • Number of events 69 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood alkaline phosphatase increased	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.9% 50/562 • Number of events 79 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	7.8% 22/281 • Number of events 28 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood cholesterol increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood corticotrophin increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood iron decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood lactate dehydrogenase increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.5% 31/562 • Number of events 34 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.7% 16/281 • Number of events 17 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Blood thyroid stimulating hormone increased	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 10/562 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Cortisol decreased	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Gamma-glutamyltransferase increased	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 20/562 • Number of events 35 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 8/281 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Haemoglobin decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.5% 14/562 • Number of events 19 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Lipase increased	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Lymphocyte count decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.3% 30/562 • Number of events 88 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.7% 2/12 • Number of events 17 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 11/281 • Number of events 32 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Lymphocyte percentage decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 38 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Neutrophil count decreased	15.4% 2/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	50.0% 5/10 • Number of events 17 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	22.8% 128/562 • Number of events 668 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	33.3% 4/12 • Number of events 29 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.0% 76/281 • Number of events 310 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Neutrophil percentage decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 24 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Platelet count decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	15.5% 87/562 • Number of events 350 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.7% 2/12 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	15.7% 44/281 • Number of events 125 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Weight decreased	7.7% 1/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	40.0% 4/10 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.9% 50/562 • Number of events 55 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.3% 12/281 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations Weight increased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.5% 14/562 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.5% 7/281 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Investigations White blood cell count decreased	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	50.0% 5/10 • Number of events 20 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.9% 106/562 • Number of events 502 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	33.3% 4/12 • Number of events 29 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.6% 55/281 • Number of events 211 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Decreased appetite	61.5% 8/13 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	21.0% 118/562 • Number of events 140 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	13.9% 39/281 • Number of events 49 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.8% 27/562 • Number of events 40 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 11/281 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 48 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.6% 9/562 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 8/281 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 28 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.2% 18/562 • Number of events 28 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 11/281 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.0% 28/562 • Number of events 46 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.0% 14/281 • Number of events 19 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.7% 15/562 • Number of events 23 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Metabolism and nutrition disorders Hyponatraemia	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 12/562 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.5% 7/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Arthralgia	30.8% 4/13 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	21.7% 122/562 • Number of events 203 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	17.1% 48/281 • Number of events 73 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Back pain	15.4% 2/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	12.8% 72/562 • Number of events 88 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	14.6% 41/281 • Number of events 48 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 22/562 • Number of events 25 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	6.0% 17/281 • Number of events 21 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Coccydynia	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.0% 28/562 • Number of events 31 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.6% 13/281 • Number of events 16 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.5% 59/562 • Number of events 83 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	12.1% 34/281 • Number of events 57 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.4% 25/562 • Number of events 28 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	7.1% 20/281 • Number of events 23 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Pain in extremity	23.1% 3/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 56/562 • Number of events 68 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	14.6% 41/281 • Number of events 47 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 10/562 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Ataxia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Dementia Alzheimer's type	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.3% 52/562 • Number of events 61 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.5% 24/281 • Number of events 33 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Dysgeusia	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.6% 54/562 • Number of events 63 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.3% 15/281 • Number of events 18 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Headache	15.4% 2/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	50.0% 5/10 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.8% 111/562 • Number of events 184 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	23.5% 66/281 • Number of events 104 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Lethargy	7.7% 1/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 15 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Mental impairment	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Neuropathy peripheral	30.8% 4/13 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	11.0% 62/562 • Number of events 72 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	12.5% 35/281 • Number of events 50 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Neurotoxicity	15.4% 2/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Paraesthesia	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.3% 24/562 • Number of events 31 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.3% 15/281 • Number of events 15 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Peripheral motor neuropathy	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Peripheral sensory neuropathy	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.7% 49/562 • Number of events 55 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	7.1% 20/281 • Number of events 22 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Polyneuropathy	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 12/562 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Presyncope	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Somnolence	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.6% 9/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Nervous system disorders Taste disorder	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 8/562 • Number of events 9 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 5/281 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Anxiety	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.3% 3/11 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.1% 23/562 • Number of events 23 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 11/281 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Depressed mood	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Depression	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 20/562 • Number of events 20 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.6% 13/281 • Number of events 13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Insomnia	7.7% 1/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.5% 48/562 • Number of events 53 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 28/281 • Number of events 32 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Persistent depressive disorder	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Psychiatric disorders Stress	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Dysuria	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 12/562 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Polyuria	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Renal and urinary disorders Renal impairment	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	16.7% 2/12 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Reproductive system and breast disorders Breast pain	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.3% 24/562 • Number of events 29 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.0% 14/281 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	40.0% 4/10 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	21.0% 118/562 • Number of events 154 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	17.4% 49/281 • Number of events 60 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 22/562 • Number of events 23 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	12.3% 69/562 • Number of events 82 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	13.2% 37/281 • Number of events 44 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.8% 5/281 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 20/562 • Number of events 26 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	6.0% 17/281 • Number of events 20 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	5.2% 29/562 • Number of events 32 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	6.4% 18/281 • Number of events 25 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 12/562 • Number of events 12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.6% 13/281 • Number of events 15 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.7% 1/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Sinus congestion	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Alopecia	30.8% 4/13 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	50.0% 5/10 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	18.2% 2/11 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	33.8% 190/562 • Number of events 194 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	34.5% 97/281 • Number of events 97 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Butterfly rash	7.7% 1/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/562 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.1% 6/281 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 8 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Drug eruption	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 16/562 • Number of events 18 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 10/281 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Erythema	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.1% 23/562 • Number of events 25 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 11/281 • Number of events 18 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Nail discolouration	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 10/281 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Nail dystrophy	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Onychalgia	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.18% 1/562 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Pruritus	23.1% 3/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	15.1% 85/562 • Number of events 120 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	11.4% 32/281 • Number of events 39 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Rash	15.4% 2/13 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	20.0% 2/10 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	27.3% 3/11 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	19.6% 110/562 • Number of events 154 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	12.1% 34/281 • Number of events 44 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	30.0% 3/10 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	4.4% 25/562 • Number of events 41 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 10/281 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.53% 3/562 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 6/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.2% 7/562 • Number of events 7 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Skin lesion	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 4/562 • Number of events 5 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.4% 4/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 2/562 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/281 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 15 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 4 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Deep vein thrombosis	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.6% 9/562 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	8.3% 1/12 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.36% 1/281 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Flushing	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 22 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	1.1% 3/281 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Haematoma	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.89% 5/562 • Number of events 6 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.71% 2/281 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Hot flush	7.7% 1/13 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	10.0% 1/10 • Number of events 2 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.7% 21/562 • Number of events 22 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.6% 10/281 • Number of events 14 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Hypotension	23.1% 3/13 • Number of events 3 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.0% 11/562 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.2% 9/281 • Number of events 10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
Vascular disorders Lymphoedema	0.00% 0/13 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/10 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	9.1% 1/11 • Number of events 1 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	2.8% 16/562 • Number of events 17 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	0.00% 0/12 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..	3.9% 11/281 • Number of events 11 • Up to approximately 81 months All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
• Publication restrictions are in place

Restriction type: OTHER