Trial Outcomes & Findings for A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC (NCT NCT04063163)

NCT ID: NCT04063163

Last Updated: 2025-12-09

Results Overview

Overall survival (OS)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

585 participants

Primary outcome timeframe

The period from randomization through death regardless of causality (up to approximately 56 months)

Results posted on

2025-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Group A HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics	Group B Placebo+chemotherapy (Carboplatin-Etoposide) carboplatin and etoposide: chemotherapeutics placebo: placebo
Overall Study STARTED	389	196
Overall Study COMPLETED	77	12
Overall Study NOT COMPLETED	312	184

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics	Group B Placebo+chemotherapy (Carboplatin-Etoposide) carboplatin and etoposide: chemotherapeutics placebo: placebo
Overall Study Death	281	166
Overall Study Lost to Follow-up	12	8
Overall Study Withdrawal by Subject	19	10

Baseline Characteristics

A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=389 Participants HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics	Group B n=196 Participants Placebo+chemotherapy (Carboplatin-Etoposide) carboplatin and etoposide: chemotherapeutics placebo: placebo	Total n=585 Participants Total of all reporting groups
Age, Continuous	63 years n=4 Participants	62 years n=50 Participants	62 years n=518 Participants
Sex: Female, Male Female	72 Participants n=4 Participants	164 Participants n=50 Participants	236 Participants n=518 Participants
Sex: Female, Male Male	317 Participants n=4 Participants	32 Participants n=50 Participants	349 Participants n=518 Participants
Race/Ethnicity, Customized Asian	262 Participants n=4 Participants	139 Participants n=50 Participants	401 Participants n=518 Participants
Race/Ethnicity, Customized Non-Asian	127 Participants n=4 Participants	57 Participants n=50 Participants	184 Participants n=518 Participants
Smoking history Never smoker	81 Participants n=4 Participants	35 Participants n=50 Participants	116 Participants n=518 Participants
Smoking history Current smoker	102 Participants n=4 Participants	48 Participants n=50 Participants	150 Participants n=518 Participants
Smoking history Former smoker	206 Participants n=4 Participants	113 Participants n=50 Participants	319 Participants n=518 Participants

PRIMARY outcome

Timeframe: The period from randomization through death regardless of causality (up to approximately 56 months)

Population: Analyses of the primary efficacy endpoint is based on the ITT. The ITT Population comprises all participants to whom study intervention has been randomized.

Overall survival (OS)

Outcome measures

Outcome measures
Measure	B Groups n=196 Participants Placebo+chemotherapy (Carboplatin-Etoposide)	A Groups n=389 Participants HLX10+chemotherapy (Carboplatin-Etoposide)
OS	11.10 month Interval 9.955 to 12.353	15.77 month Interval 13.897 to 17.413

SECONDARY outcome

Timeframe: From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).

Population: Analysis of PFS is based on ITT.

PFS is defined as a period from randomization initiation to the first documentation of PD or death regardless of causality (whichever occurs first).

Outcome measures

Outcome measures
Measure	B Groups n=196 Participants Placebo+chemotherapy (Carboplatin-Etoposide)	A Groups n=389 Participants HLX10+chemotherapy (Carboplatin-Etoposide)
Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1	4.34 month Interval 4.205 to 4.435	5.82 month Interval 5.552 to 6.932

SECONDARY outcome

Timeframe: From baseline until PR or CR, whichever occurs first (up to approximately 56 months)

Population: ORR is analyzed based on ITT.

The ORR is defined as the proportion of subjects with a best overall response of CR or PR, according to RECIST 1.1. The best overall response will be defined as the best response across all time points in the order of CR, PR, SD, PD, and not NE.

Outcome measures

Outcome measures
Measure	B Groups n=196 Participants Placebo+chemotherapy (Carboplatin-Etoposide)	A Groups n=389 Participants HLX10+chemotherapy (Carboplatin-Etoposide)
Objective Response Rate	115 Participants	268 Participants

SECONDARY outcome

Timeframe: From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).

Population: DOR is analyzed based on ITT.

DOR is defined as a period from the first documentation of response (CR or PR) through the first documentation of PD or death (whichever occurs first).

Outcome measures

Outcome measures
Measure	B Groups n=196 Participants Placebo+chemotherapy (Carboplatin-Etoposide)	A Groups n=389 Participants HLX10+chemotherapy (Carboplatin-Etoposide)
Duration of Response	4.17 month Interval 3.055 to 4.205	6.80 month Interval 5.52 to 8.345

Adverse Events

Group A

Serious events: 146 serious events

Other events: 367 other events

Deaths: 224 deaths

Group B

Serious events: 71 serious events

Other events: 187 other events

Deaths: 140 deaths

Serious adverse events

Other adverse events

Additional Information

Fan Zhang

ShanghaiHenliusBiotech

Phone: 021-33395800*6334

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Group A n=389 participants at risk HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics	Group B n=196 participants at risk Placebo+chemotherapy (Carboplatin-Etoposide) carboplatin and etoposide: chemotherapeutics placebo: placebo
Blood and lymphatic system disorders platelet count decreased	6.4% 25/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	7.7% 15/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Neutrophil count decreased	4.4% 17/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	5.6% 11/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Alanine aminotransferase increased	1.5% 6/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Aspartate aminotransferase increased	0.77% 3/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Blood ketone body increased	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Fibrin D dimer increased	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Gamma-glutamyltransferase increased	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Red blood cell count decreased	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Disease progression	7.5% 29/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	9.7% 19/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Gastrointestinal disorders Death	2.8% 11/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	3.6% 7/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Pyrexia	1.0% 4/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	1.0% 2/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Sudden death	0.77% 3/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Asthenia	0.00% 0/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	1.5% 3/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Fatigue	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Non-cardiac chest pain	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Multiple organ dysfunction syndrome	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders General physical health deterioration	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Pneumonia	3.6% 14/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	3.6% 7/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations COVID-19	1.3% 5/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Septic shock	0.51% 2/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations COVID-19 pneumonia	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Device related infection	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Gastroenteritis	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Infection	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Lip infection	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Lung abscess	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Meningoencephalitis herpetic	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Pneumonia bacterial	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Sepsis	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Intracranial infection	0.00% 0/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Pneumonia aspiration	0.00% 0/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Urinary tract infection	0.00% 0/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Infections and infestations Viral infection	0.00% 0/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Neutropenia	2.8% 11/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	2.0% 4/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Thrombocytopenia	2.8% 11/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	2.0% 4/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Leukopenia	2.3% 9/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	1.5% 3/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Anaemia	1.5% 6/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	2.6% 5/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Febrile neutropenia	0.51% 2/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	1.5% 3/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Myelosuppression	0.26% 1/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.00% 0/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	0.51% 1/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.

Other adverse events
Measure	Group A n=389 participants at risk HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics	Group B n=196 participants at risk Placebo+chemotherapy (Carboplatin-Etoposide) carboplatin and etoposide: chemotherapeutics placebo: placebo
Blood and lymphatic system disorders Anaemia	71.7% 279/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	70.9% 139/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Neutropenia	29.6% 115/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	30.1% 59/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Leukopenia	23.9% 93/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	19.9% 39/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Blood and lymphatic system disorders Thrombocytopenia	18.0% 70/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	13.8% 27/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Neutrophil count decreased	55.8% 217/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	49.0% 96/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations White blood cell count decreased	52.7% 205/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	50.0% 98/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Platelet count decreased	40.4% 157/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	43.4% 85/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Alanine aminotransferase increased	18.3% 71/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	18.9% 37/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Lymphocyte count decreased	18.0% 70/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	14.8% 29/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Aspartate aminotransferase increased	15.9% 62/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	16.8% 33/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Blood alkaline phosphatase increased	12.3% 48/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	8.7% 17/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Blood lactate dehydrogenase increased	11.1% 43/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	9.2% 18/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Weight decreased	10.5% 41/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	9.2% 18/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Weight increased	11.1% 43/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	7.1% 14/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Gamma-glutamyltransferase increased	10.0% 39/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	6.6% 13/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Blood cholesterol increased	9.3% 36/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	2.0% 4/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Blood bilirubin increased	5.1% 20/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	6.1% 12/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Investigations Blood creatinine increased	5.1% 20/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	5.1% 10/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Decreased appetite	28.0% 109/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	28.6% 56/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hyponatraemia	24.4% 95/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	13.3% 26/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypoalbuminaemia	18.8% 73/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	14.8% 29/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypertriglyceridaemia	16.7% 65/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	12.2% 24/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypokalaemia	14.9% 58/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	7.1% 14/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hyperglycaemia	12.9% 50/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	7.7% 15/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypercholesterolaemia	11.3% 44/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	9.7% 19/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hyperuricaemia	10.5% 41/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	8.7% 17/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypocalcaemia	10.3% 40/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	5.1% 10/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypomagnesaemia	8.5% 33/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	4.6% 9/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypochloraemia	7.5% 29/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	5.6% 11/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypoproteinaemia	8.0% 31/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	4.1% 8/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hyperlipidaemia	5.9% 23/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	1.0% 2/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Metabolism and nutrition disorders Hypophosphataemia	5.1% 20/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	2.6% 5/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Gastrointestinal disorders Nausea	36.0% 140/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	43.9% 86/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Gastrointestinal disorders Constipation	24.2% 94/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	29.6% 58/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Gastrointestinal disorders Vomiting	20.1% 78/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	29.6% 58/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Gastrointestinal disorders Diarrhoea	9.8% 38/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	6.6% 13/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Skin and subcutaneous tissue disorders Alopecia	54.2% 211/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	56.6% 111/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
Skin and subcutaneous tissue disorders Rash	7.7% 30/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	4.1% 8/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Pyrexia	15.4% 60/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	12.2% 24/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
General disorders Asthenia	11.6% 45/389 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.	13.3% 26/196 • From ICF until 90 days after the last study treatment (up to approximately 56 months). All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.