Trial Outcomes & Findings for Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression (NCT NCT04251169)

NCT ID: NCT04251169

Last Updated: 2025-06-03

Results Overview

ORR defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months.
• Results posted on: 2025-06-03

Participant Flow

Participants were recruited from seven hospitals across Spain based on predefined eligibility criteria. The first participant was enrolled on September 16, 2020, and the last participant completed the study on April 30, 2024.

A total of 162 patients were assessed for eligibility. Of these, 35 were excluded due to unsuitable or unavailable tumor samples (21), exclusion criteria (11), or consent withdrawal (3). The remaining 126 underwent PAM50 molecular pre-screening, and 21 were identified as having HER2-enriched or basal-like tumors, making them eligible for the trial. Among these 21 eligible patients, 20 were enrolled, while one was not recruited due to the trial closing prematurely.

Participant milestones

Measure	Pembrolizumab + Paclitaxel Pembrolizumab 200 mg every 3 weeks (on day 1 \[D1\] of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes intravenous (IV) infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression

Baseline characteristics by cohort

Measure	Pembrolizumab + Paclitaxel n=20 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Arabic or North African	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	16 Participants n=5 Participants
Race/Ethnicity, Customized Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants
Region of Enrollment Spain	20 participants n=5 Participants
Previous (neo)adjuvant chemotherapy (CT)	15 participants n=5 Participants
Menopausal status Premenopausal	3 Participants n=5 Participants
Menopausal status Postmenopausal	17 Participants n=5 Participants
Lines of endocrine therapy (ET) for metastatic breast cancer (mBC) 1	17 Participants n=5 Participants
Lines of endocrine therapy (ET) for metastatic breast cancer (mBC) 2	1 Participants n=5 Participants
Lines of endocrine therapy (ET) for metastatic breast cancer (mBC) 3	2 Participants n=5 Participants
Most recent treatment line AI + CDK4/6i	5 Participants n=5 Participants
Most recent treatment line Fulvestrant + CDK46i	12 Participants n=5 Participants
Most recent treatment line Fulvestrant + Alpelisib	2 Participants n=5 Participants
Most recent treatment line Exemestane + Everolimus	1 Participants n=5 Participants
Type of cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) Abemaciclib	5 Participants n=5 Participants
Type of cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) Palbociclib	4 Participants n=5 Participants
Type of cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) Ribociclib	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months.

Population: Two patients exited the trial prior to their first post-baseline tumor assessment, and were thus excluded from the ORR analysis. The reasons for early study exit were rapid clinical progression and investigator's decision due to a drug-unrelated concomitant condition, respectively. There are 18 out of the 20 total patients evaluable for this outcome as defined in the protocol.

ORR defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

Outcome measures

Measure	Pembrolizumab + Paclitaxel n=18 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Overall Response Rate of Pembrolizumab in Combination With Paclitaxel in HR+/HER2- Non-luminal Subtype Advanced Breast Cancer Defined by the PAM50 Assay NO	7 Participants
Overall Response Rate of Pembrolizumab in Combination With Paclitaxel in HR+/HER2- Non-luminal Subtype Advanced Breast Cancer Defined by the PAM50 Assay YES	11 Participants

SECONDARY outcome

Timeframe: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months.

Population: Two patients exited the trial prior to their first post-baseline tumor assessment, and were thus excluded from the CBR analysis. The reasons for early study exit were rapid clinical progression and investigator's decision due to a drug-unrelated concomitant condition, respectively. There are 18 out of the 20 total patients evaluable for this outcome as defined in the protocol.

Proportion of patients with a best overall response of CR, PR or an overall lesion response of Stable Disease (SD) or Non-PR/Non-progression disease (PD) lasting ≥ 24 weeks, based on local investigator´s assessment according to RECIST v1.1.

The CBR and its exact 90% confidence interval (CI).

Outcome measures

Measure	Pembrolizumab + Paclitaxel n=18 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Clinical Benefit Rate (CBR) NO	1 Participants
Clinical Benefit Rate (CBR) YES	17 Participants

SECONDARY outcome

Timeframe: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months.

PFS is defined as the time from the date of allocation to the date of the first documented progression or death due to any cause occurring in the study. PFS will be assessed based on local investigator's assessment according to RECIST v1.1.

PFS will be censored if no PFS event is observed before the cut-off date. The censoring date will be the date of last adequate tumor assessment before the cut-off date. If a PFS event is observed after two or more missing or non-adequate tumor assessments, then PFS will be censored at the last adequate tumor assessment. If a PFS event is observed after a single missing or non-adequate tumor assessment, the actual date of event will be used. It is not intended to censor patients for new anticancer therapy prior to documented disease progression in the primary analysis.

Outcome measures

Measure

Pembrolizumab + Paclitaxel n=20 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab

Progression Free Survival (PFS)

8.1 months Interval 5.9 to 10.4

SECONDARY outcome

Timeframe: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months.

Time from the first occurrence of a documented objective response to disease progression, as determined locally by the investigator through use of RECIST v.1.1, or death from any cause, whichever occurs first.

DOR only applies to patients whose best overall response is CR or PR according to RECIST v1.1 based on tumor response data per local investigator's assessment. The start date is the date of first documented response of CR or PR (i.e., the start date of response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying cancer. Patients continuing without progression or death due to underlying cancer will be censored at the date of their last adequate tumor assessment.

Outcome measures

Measure

Pembrolizumab + Paclitaxel n=11 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab

Duration of Response (DoR)

6.3 months Interval 3.7 to 31.1

SECONDARY outcome

Timeframe: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months.

Time from allocation to the first objective tumor response (tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR.

TtR only applies to patients whose best overall response is CR or PR according to RECIST v1.1 based on tumor response data per local investigator's assessment.

Outcome measures

Measure

Pembrolizumab + Paclitaxel n=11 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab

Time to Response (TtR)

3.9 months Interval 3.9 to 5.9

SECONDARY outcome

Timeframe: From date of randomization to death, unacceptable toxicity, consent withdrawal or study termination, whichever came first, assessed after a median follow-up of 26 months (interquartile range [IQR]: 16.6-not reached [NR]).

Time from allocation to death from any cause. Data for patients who are alive at the time of the analysis data cutoff will be censored at the last date they were known to be alive. Data from patients without post-baseline information will be censored at the date of allocation.

The results from log-rank test will be provided. The OS curve will be estimated by the Kaplan-Meier methodology, and the 95% CI will be estimated by the Cox proportional-hazards models.

Outcome measures

Measure

Pembrolizumab + Paclitaxel n=20 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab

Overall Survival (OS)

26 months Interval 18.0 to The upper limit of the 95% CI could not be estimated using the Kaplan-Meier method. The upper bound of the confidence interval is 'not reached' due to an insufficient number of overall survival events. The Kaplan-Meier method requires a minimum number of events to estimate this value reliably. The study was terminated before enough events had occurred, and the calculation could not be performed based on the data available at the time of study closure.

SECONDARY outcome

Timeframe: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months.

Time from allocation to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurs first compared to PFS on prior line of therapy.

Pre-PFS only applies to patients whose received have previous treatment for metastatic disease. The average of the Pre-PFS/PFS ratios will be calculated.

Outcome measures

Measure

Pembrolizumab + Paclitaxel n=18 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab

PFS on Study Treatment Compared to PFS on Prior Line of Therapy (Pre-PFS)

1.10 Ratio Standard Deviation 0.64

SECONDARY outcome

Timeframe: Toxicities were assessed during the whole treatment period (from baseline until 90 days after a patients' final treatment, up to 35 months).

Incidence, duration and severity of AEs assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5,

Outcome measures

Measure	Pembrolizumab + Paclitaxel n=20 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Incidence, Duration and Severity of Adverse Events (AEs) of the Combination of Pembrolizumab With Paclitaxel Patients with TRAEs · Yes	19 Participants
Incidence, Duration and Severity of Adverse Events (AEs) of the Combination of Pembrolizumab With Paclitaxel Patients with TRAEs · No	1 Participants
Incidence, Duration and Severity of Adverse Events (AEs) of the Combination of Pembrolizumab With Paclitaxel Grade 3 TRAEs · Yes	9 Participants
Incidence, Duration and Severity of Adverse Events (AEs) of the Combination of Pembrolizumab With Paclitaxel Grade 3 TRAEs · No	11 Participants
Incidence, Duration and Severity of Adverse Events (AEs) of the Combination of Pembrolizumab With Paclitaxel Grade 4-5 TRAEs · Yes	0 Participants
Incidence, Duration and Severity of Adverse Events (AEs) of the Combination of Pembrolizumab With Paclitaxel Grade 4-5 TRAEs · No	20 Participants

SECONDARY outcome

Timeframe: Tolerability will be assessed during the whole treatment period (from baseline until patients' final treatment which is defined as the end of the Treatment Phase of the study, up to 34 months).

Quantification of dose interruptions, reductions, dose intensity, delays and treatment discontinuation will be recorded in the electronic case report form (eCRF)

Outcome measures

Measure	Pembrolizumab + Paclitaxel n=20 Participants Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Number of Patients With Dose Interruptions, Reductions, Delays and Treatment Discontinuation of the Combination of Pembrolizumab With Paclitaxel Discontinuations due disease progression	13 Participants
Number of Patients With Dose Interruptions, Reductions, Delays and Treatment Discontinuation of the Combination of Pembrolizumab With Paclitaxel Discontinuations Due to Adverse Events	2 Participants

Adverse Events

Pembrolizumab + Paclitaxel

Serious events: 7 serious events

Other events: 20 other events

Deaths: 12 deaths

Serious adverse events

Measure	Pembrolizumab + Paclitaxel n=20 participants at risk Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Gastritis	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Respiratory, thoracic and mediastinal disorders Pulmonary tumour thrombotic microangiopathy	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Endocrine disorders Adrenal insufficiency	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Fatigue	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Hepatobiliary disorders Hepatitis	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.

Other adverse events

Measure	Pembrolizumab + Paclitaxel n=20 participants at risk Pembrolizumab 200 mg every 3 weeks (on D1 of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m2 administered at days 1, 8, 15 of each 21-day cycle beginning at cycle 2. Pembrolizumab: Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1 Paclitaxel: Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
Blood and lymphatic system disorders Anemia	60.0% 12/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Blood and lymphatic system disorders Neutropenia	55.0% 11/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Blood and lymphatic system disorders Lymphopenia	40.0% 8/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Blood and lymphatic system disorders osinophilia	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Blood and lymphatic system disorders Leukopenia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Diarrhoea	40.0% 8/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Constipation	30.0% 6/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders nausea	25.0% 5/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Abdominal pain	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Haemorrhoids	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Stomatitis	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Vomiting	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders dyspepsia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders dysphagia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Inguinal hernia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Gastrointestinal disorders Rectal haemorrhage	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Neurotoxicity	45.0% 9/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders neuropathy peripheral	30.0% 6/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Headache	25.0% 5/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Dizziness	20.0% 4/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Paraesthesia	20.0% 4/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Dysgeusia	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Polyneuropathy	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Ataxia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Dystonia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Nervous system disorders Neuralgia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Fatigue	70.0% 14/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Oedema	25.0% 5/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Pyrexia	25.0% 5/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Chest pain	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Chills	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Mucosal dryness	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
General disorders Pain	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Rash	70.0% 14/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Alopecia	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Erythema	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Onycholysis	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Pruritus	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Nail dystrophy	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders nail pigmentation	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Onychalgia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Skin and subcutaneous tissue disorders Skin toxicity	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Pain in extremity	35.0% 7/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 5/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Back pain	20.0% 4/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	20.0% 4/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Limb discomfort	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Muscle spasms	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Muscular weakness	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Periarthritis	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Musculoskeletal and connective tissue disorders Sacral pain	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations transaminases increased	40.0% 8/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood cholesterol increased	20.0% 4/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood triglycerides increased	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood alkaline phosphatase increased	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood magnesium decreased	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Bilirubin conjugated increased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood albumin decreased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood bilirubin increased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood calcium decreased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood lactate dehydrogenase increased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Blood thyroid stimulating hormone increased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Gamma-glutamyltransferase increased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Investigations Tri-iodothyronine decreased	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations COVID-19	25.0% 5/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Urinary tract infection	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Cystitis	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Device related infection	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Gastrointestinal infection	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations gingivitis	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Herpes zoster	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Lymphangitis	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Nasopharyngitis	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Oral herpes	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Respiratory tract infection	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Systemic candida	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Upper respiratory tract infection	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Infections and infestations Viral infection	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Endocrine disorders Hypothyroidism	25.0% 5/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Endocrine disorders Hyperthyroidism	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Decreased appetite	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Diabetes mellitus	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Hypercalcaemia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Hypercholesterolaemia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Hyperglycaemia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Hypocalcaemia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Hypomagnesaemia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Metabolism and nutrition disorders Weight loss poor	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Respiratory, thoracic and mediastinal disorders dyspnoea	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Respiratory, thoracic and mediastinal disorders Aphonia	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Vascular disorders Lymphoedema	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Vascular disorders Diastolic hypertension	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Vascular disorders Hot flush	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Vascular disorders Hypotension	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Injury, poisoning and procedural complications Infusion related reaction	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Injury, poisoning and procedural complications Immunisation reaction	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Injury, poisoning and procedural complications Limb injury	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Eye disorders Dry eye	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Eye disorders Visual acuity reduced	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Psychiatric disorders depression	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Psychiatric disorders Anxiety	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Renal and urinary disorders Dysuria	10.0% 2/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Renal and urinary disorders Renal impairment	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Reproductive system and breast disorders Breast pain	15.0% 3/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Reproductive system and breast disorders Breast ulceration	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	5.0% 1/20 • Treatment-emergent adverse events (TEAEs) were events occurring after first study drug administration, absent at baseline or worsened by treatment. Deaths and serious adverse events (SAEs) were recorded from treatment start until 90 days post-final dose or 30 days post-treatment if new anti-cancer therapy began. Non-fatal adverse events (AEs) were recorded until 30 days post-treatment or until new therapy started, whichever came first. Data was collected for up to 35 months.

Additional Information

Sara Cano

SOLTI

Phone: 34 664 449 862

Email: info@gruposolti.org

Results disclosure agreements

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