Trial Outcomes & Findings for Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NCT NCT03732677)

Last Updated: 2025-11-21

Results Overview

pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

1063 participants

Primary outcome timeframe

Up to 6 months

Results posted on

2025-11-21

Participant Flow

Patients randomized to treatments Arm 1 or Arm 2, will be treated according to their renal function. Recruitment for borderline renal function patients will be limited to up to 20% of the targeted global population. Recruitment for patients with T2N0 disease will be limited to approximately 40% of the targeted global population; once the 40% cap has been reached, only T2-4N1M0 and T3-4N0M0 patients will be allowed to be enrolled onto the study. Completion status is reported by treatment phase

Participant milestones

Participant milestones
Measure	Durvalumab + Gemcitabine + Cisplatin Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Overall Study STARTED	533	530
Overall Study Started Neoadjuvant Treatment	530	526
Overall Study Completed Neoadjuvant Treatment	417	389
Overall Study Completed Radical Cystectomy	469	441
Overall Study Started Adjuvant Treatment	383	0
Overall Study Completed Adjuvant Treatment	288	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	533	530

Reasons for withdrawal

Reasons for withdrawal
Measure	Durvalumab + Gemcitabine + Cisplatin Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Overall Study Terminated the study	154	197
Overall Study Continuing study off treatment	379	333

Baseline Characteristics

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Total n=1063 Participants Total of all reporting groups
Age, Continuous	64.1 Years STANDARD_DEVIATION 8.9 • n=68 Participants	64.6 Years STANDARD_DEVIATION 8.9 • n=76 Participants	64.4 Years STANDARD_DEVIATION 8.9 • n=48 Participants
Sex: Female, Male Female	96 Participants n=68 Participants	97 Participants n=76 Participants	193 Participants n=48 Participants
Sex: Female, Male Male	437 Participants n=68 Participants	433 Participants n=76 Participants	870 Participants n=48 Participants
Race/Ethnicity, Customized HISPANIC OR LATINO	44 Participants n=68 Participants	41 Participants n=76 Participants	85 Participants n=48 Participants
Race/Ethnicity, Customized MISSING	14 Participants n=68 Participants	22 Participants n=76 Participants	36 Participants n=48 Participants
Race/Ethnicity, Customized NOT HISPANIC OR LATINO	483 Participants n=68 Participants	477 Participants n=76 Participants	960 Participants n=48 Participants
Race/Ethnicity, Customized ASIAN	152 Participants n=68 Participants	145 Participants n=76 Participants	297 Participants n=48 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	6 Participants n=68 Participants	4 Participants n=76 Participants	10 Participants n=48 Participants
Race/Ethnicity, Customized OTHER	7 Participants n=68 Participants	1 Participants n=76 Participants	8 Participants n=48 Participants
Race/Ethnicity, Customized WHITE	354 Participants n=68 Participants	358 Participants n=76 Participants	712 Participants n=48 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Full Analysis Set (Intention to Treat): includes all randomized subjects

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Pathologic Complete Response (pCR) Rates at Time of Cystectomy	199 Participants	146 Participants

PRIMARY outcome

Timeframe: Up to 48 months

Population: The full analysis set (FAS) includes all randomized patients

EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event	NA months Interval 13.4 to Median EFS was not reached due to insufficient number of participants with events 75th percentile EFS was not reached due to insufficient number of participants with events.	46.1 months Interval 8.6 to 75th percentile EFS was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 24 months

Population: The full analysis set (FAS) Intention to treat included all randomized patients

EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event	67.8 Percentage of participants Interval 63.6 to 71.7	59.8 Percentage of participants Interval 55.4 to 64.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: The full analysis set (FAS) Intention to treat included all randomized patients.

The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS.

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Proportion of Patients Who Undergo Cystectomy	469 Participants	441 Participants

SECONDARY outcome

Timeframe: Up to 65 months

OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1)

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Overall Survival	NA Months Interval 41.9 to Median OS was not reached due to insufficient number of participants with events 75th percentile OS was not reached due to insufficient number of participants with events.	NA Months Interval 24.1 to Median OS was not reached due to insufficient number of participants with events 75th percentile OS was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 48 months

Population: The full analysis set (FAS) Intention to treat included all randomized patients.

MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.	NA Months Interval 24.2 to Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.	NA Months Interval 15.0 to Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 48 months

Population: The full analysis set (FAS) Intention to treat included all randomized patients.

DSS is defined as the time from the date of randomization until death due to bladder cancer

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=533 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=530 Participants Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Disease-specific Survival Per Investigator Assessment or Local Biopsy Review.	NA months Median DSS was not reached due to insufficient number of participants with events 25th and 75th percentile DSS were not reached due to insufficient number of participants with events.	NA months Interval 50.9 to Median DSS was not reached due to insufficient number of participants with events 75th percentile DSS was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 12 months

Population: The ADA analysis set includes all participants who had non-missing baseline ADA and at least one non-missing post-baseline ADA result.

Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.

Outcome measures

Outcome measures
Measure	Durvalumab + Gemcitabine + Cisplatin n=453 Participants Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) ADA positive at any visit (ADA prevalence)	37 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) Treatment-emergent ADA positive (ADA Incidence)	8 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) Treatment-boosted ADA	1 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) Treatment-induced ADA (Positive Post-baseline only)	7 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) ADA Positive at Baseline only	29 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) ADA Positive Post-baseline and Positive at Baseline	1 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) Persistently Positive	4 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) Transiently Positive	4 Participants	—
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA) nAb Positive at any visit	6 Participants	—

Adverse Events

Durvalumab + Gemcitabine + Cisplatin

Serious events: 326 serious events

Other events: 522 other events

Deaths: 27 deaths

Gemcitabine + Cisplatin

Serious events: 287 serious events

Other events: 511 other events

Deaths: 29 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Durvalumab + Gemcitabine + Cisplatin n=530 participants at risk Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=526 participants at risk Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Cardiac disorders Angina pectoris	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.38% 2/526 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Catheter site infection	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Cellulitis	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Clostridium difficile colitis	0.38% 2/530 • Number of events 3 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Clostridium difficile infection	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Cystitis	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Dengue fever	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Device related infection	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Diarrhoea infectious	0.38% 2/530 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Diverticulitis	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Endocarditis	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.38% 2/526 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Cardiac disorders Atrial fibrillation	0.38% 2/530 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Erysipelas	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Escherichia infection	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Escherichia sepsis	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Fungaemia	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Fungal endocarditis	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Fungal peritonitis	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Gastroenteritis	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Haematological infection	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Infected lymphocele	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Infection	0.38% 2/530 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Cardiac disorders Cardiac arrest	0.38% 2/530 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Influenza	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Kidney infection	0.38% 2/530 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.38% 2/526 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Klebsiella bacteraemia	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Osteomyelitis	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Pelvic abscess	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Pelvic infection	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Perineal abscess	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Perinephric abscess	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Peritonitis	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Pneumonia	2.3% 12/530 • Number of events 12 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.95% 5/526 • Number of events 6 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Cardiac disorders Cardiac failure	0.38% 2/530 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.38% 2/526 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Pneumonia aspiration	0.38% 2/530 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Pneumonia bacterial	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Pneumonia mycoplasmal	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.00% 0/526 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Pneumonia parainfluenzae viral	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Post procedural infection	0.19% 1/530 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.19% 1/526 • Number of events 1 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Infections and infestations Postoperative abscess	0.00% 0/530 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	0.38% 2/526 • Number of events 2 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.

Other adverse events
Measure	Durvalumab + Gemcitabine + Cisplatin n=530 participants at risk Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	Gemcitabine + Cisplatin n=526 participants at risk Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Infections and infestations Urinary tract infection	23.4% 124/530 • Number of events 181 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	20.5% 108/526 • Number of events 158 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Injury, poisoning and procedural complications Procedural pain	8.7% 46/530 • Number of events 49 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	7.2% 38/526 • Number of events 43 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations Alanine aminotransferase increased	8.7% 46/530 • Number of events 65 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	7.2% 38/526 • Number of events 48 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations Amylase increased	6.4% 34/530 • Number of events 43 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	3.6% 19/526 • Number of events 26 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations Blood creatinine increased	17.7% 94/530 • Number of events 131 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	14.4% 76/526 • Number of events 97 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations Lipase increased	7.4% 39/530 • Number of events 49 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	5.1% 27/526 • Number of events 32 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations Neutrophil count decreased	15.1% 80/530 • Number of events 121 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	13.7% 72/526 • Number of events 102 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations Platelet count decreased	6.6% 35/530 • Number of events 48 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	6.1% 32/526 • Number of events 43 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations Weight decreased	7.7% 41/530 • Number of events 41 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	5.1% 27/526 • Number of events 28 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Investigations White blood cell count decreased	5.3% 28/530 • Number of events 47 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	6.7% 35/526 • Number of events 58 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Metabolism and nutrition disorders Decreased appetite	26.4% 140/530 • Number of events 196 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	24.9% 131/526 • Number of events 175 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Blood and lymphatic system disorders Anaemia	37.7% 200/530 • Number of events 257 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	38.0% 200/526 • Number of events 239 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Metabolism and nutrition disorders Hyperglycaemia	5.5% 29/530 • Number of events 33 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	4.4% 23/526 • Number of events 24 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Metabolism and nutrition disorders Hyperkalaemia	8.3% 44/530 • Number of events 58 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	4.9% 26/526 • Number of events 30 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Metabolism and nutrition disorders Hypokalaemia	5.8% 31/530 • Number of events 47 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	4.4% 23/526 • Number of events 34 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Metabolism and nutrition disorders Hypomagnesaemia	10.6% 56/530 • Number of events 77 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	10.5% 55/526 • Number of events 73 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Musculoskeletal and connective tissue disorders Arthralgia	10.2% 54/530 • Number of events 65 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	6.7% 35/526 • Number of events 39 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Musculoskeletal and connective tissue disorders Back pain	9.4% 50/530 • Number of events 57 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	8.7% 46/526 • Number of events 54 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Musculoskeletal and connective tissue disorders Myalgia	6.0% 32/530 • Number of events 35 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	2.5% 13/526 • Number of events 13 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 27/530 • Number of events 27 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	5.3% 28/526 • Number of events 31 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Ear and labyrinth disorders Tinnitus	6.8% 36/530 • Number of events 41 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	8.2% 43/526 • Number of events 48 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Nervous system disorders Dizziness	7.9% 42/530 • Number of events 59 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	7.4% 39/526 • Number of events 43 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Endocrine disorders Hyperthyroidism	5.7% 30/530 • Number of events 31 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	1.7% 9/526 • Number of events 10 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Nervous system disorders Dysgeusia	7.5% 40/530 • Number of events 42 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	6.3% 33/526 • Number of events 38 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Nervous system disorders Headache	11.1% 59/530 • Number of events 74 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	11.2% 59/526 • Number of events 69 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Nervous system disorders Neuropathy peripheral	6.0% 32/530 • Number of events 40 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	5.5% 29/526 • Number of events 32 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Psychiatric disorders Insomnia	8.1% 43/530 • Number of events 49 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	8.6% 45/526 • Number of events 56 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Endocrine disorders Hypothyroidism	11.3% 60/530 • Number of events 64 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	2.1% 11/526 • Number of events 11 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Renal and urinary disorders Dysuria	5.3% 28/530 • Number of events 33 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	3.6% 19/526 • Number of events 20 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Gastrointestinal disorders Abdominal distension	5.3% 28/530 • Number of events 29 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	4.4% 23/526 • Number of events 27 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 36/530 • Number of events 40 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	4.6% 24/526 • Number of events 30 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 48/530 • Number of events 55 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	3.6% 19/526 • Number of events 20 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Respiratory, thoracic and mediastinal disorders Hiccups	7.7% 41/530 • Number of events 66 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	9.5% 50/526 • Number of events 66 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Skin and subcutaneous tissue disorders Alopecia	9.2% 49/530 • Number of events 50 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	10.8% 57/526 • Number of events 58 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Skin and subcutaneous tissue disorders Pruritus	15.1% 80/530 • Number of events 96 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	7.2% 38/526 • Number of events 42 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Skin and subcutaneous tissue disorders Rash	12.6% 67/530 • Number of events 81 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	5.7% 30/526 • Number of events 34 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Vascular disorders Hypertension	11.5% 61/530 • Number of events 71 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	8.0% 42/526 • Number of events 45 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Gastrointestinal disorders Abdominal pain	12.3% 65/530 • Number of events 80 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	7.4% 39/526 • Number of events 45 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Gastrointestinal disorders Abdominal pain upper	5.7% 30/530 • Number of events 38 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	4.2% 22/526 • Number of events 24 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Gastrointestinal disorders Constipation	38.5% 204/530 • Number of events 276 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.	38.2% 201/526 • Number of events 276 • Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.