Trial Outcomes & Findings for Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial (NCT NCT02406781)

Last Updated: 2025-12-10

Results Overview

Objective response is defined according to RECIST v1.1 as either complete response (disappearance of all target lesions, with any pathological lymph nodes reduced in short axis to \<10 mm) or partial response (≥30% decrease in the sum of diameters of target lesions compared with baseline). This primary endpoint is part of a dual endpoint encompassing both non-progression and objective response at 6 months (non-progression is presented as a separate primary outcome). ORR at 6 months will be evaluated only in the following strata: Stratum 1: Advanced leiomyosarcoma ; Stratum 2: Advanced undifferentiated sarcoma ; Stratum 3: Advanced other sarcoma ; Stratum 4: Advanced osteosarcoma

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

6 months from treatment initiation

Results posted on

2025-12-10

Participant Flow

8 centers: * Institut Bergonié, Pr Italiano * Centre Léon Bérard, Pr Blay * Institut Gustave Roussy, Dr Le Cesne * Centre Oscar Lambret, Dr Penel * Institut Curie, Dr Piperno-Neumann * Institut Paoli Calmette, Pr Bertucci * Institut Claudius Regaud, Dr Chevreau * Institut de Cancérologie de l'Ouest - Site René Gauducheau, Dr Bompas Planned enrollment period : 72 months Treatment duration : 2-years maximum Follow-up : 12 months Duration of study : 7 years

Participant milestones

Participant milestones
Measure	Stratum 1: Advanced Leiomyosarcoma Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced GIST Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously. Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Overall Study STARTED	15	16	16	17	10	35	20
Overall Study COMPLETED	13	14	14	15	9	30	17
Overall Study NOT COMPLETED	2	2	2	2	1	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Stratum 1: Advanced Leiomyosarcoma Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced GIST Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously. Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Overall Study Protocol Violation	2	2	2	2	1	5	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stratum 1: Advanced Leiomyosarcoma n=15 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=16 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=16 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced GIST n=17 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas n=10 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature n=35 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. n=20 Participants Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously . Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Total n=129 Participants Total of all reporting groups
Age, Continuous	63.7 years n=15 Participants	59.1 years n=16 Participants	55.5 years n=16 Participants	42.2 years n=17 Participants	57.9 years n=10 Participants	62.2 years n=35 Participants	62.7 years n=20 Participants	63 years n=129 Participants
Sex: Female, Male Female	8 Participants n=15 Participants	5 Participants n=16 Participants	6 Participants n=16 Participants	7 Participants n=17 Participants	5 Participants n=10 Participants	16 Participants n=35 Participants	10 Participants n=20 Participants	57 Participants n=129 Participants
Sex: Female, Male Male	7 Participants n=15 Participants	11 Participants n=16 Participants	10 Participants n=16 Participants	10 Participants n=17 Participants	5 Participants n=10 Participants	19 Participants n=35 Participants	10 Participants n=20 Participants	72 Participants n=129 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	15 participants n=15 Participants	16 participants n=16 Participants	16 participants n=16 Participants	17 participants n=17 Participants	10 participants n=10 Participants	35 participants n=35 Participants	20 participants n=20 Participants	129 participants n=129 Participants

PRIMARY outcome

Timeframe: 6 months from treatment initiation

Population: Population eligible and assessable for the primary endpoint: eligible patients who received at least one administration of PEMBROLIZUMAB and one administration of Metronomic CP.

Outcome measures

Outcome measures
Measure	Stratum 1: Advanced Leiomyosarcoma n=13 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced Osteosarcoma n=15 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously . Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Percentage of Participants in Objective Response at 6 Months	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	6.7 percentage of participants Interval 0.2 to 32.0	—	—	—

PRIMARY outcome

Timeframe: 6 months from treatment initiation

Population: Population eligible and assessable for the primary endpoint: eligible patients who received at least: * For all strata (except for stratum 7): one administration of PEMBROLIZUMAB and one administration of Metronomic CP * For stratum 7: one administration of PEMBROLIZUMAB and one administration of Metronomic CP and one administration of G100.

Non-progression is defined as the absence of progressive disease according to RECIST v1.1. Progressive disease defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). This outcome will be assessed as a stand-alone primary endpoint in the following strata: Stratum 5: Advanced gastrointestinal stromal tumor (GIST) ; Stratum 6: Advanced soft tissue sarcomas with immune signature ; Stratum 7: Metastatic soft tissue sarcoma (STS) In strata 1 to 4, non-progression is considered as part of the dual primary endpoint together with objective response at 6 months.

Outcome measures

Outcome measures
Measure	Stratum 1: Advanced Leiomyosarcoma n=13 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced Osteosarcoma n=15 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas n=9 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature n=30 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. n=17 Participants Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously . Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Percentage of Particpants in Non-progression at 6 Months	0.0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.2 to 33.9	14.3 percentage of participants Interval 1.8 to 42.8	13.3 percentage of participants Interval 1.7 to 40.5	11.1 percentage of participants Interval 2.8 to 48.3	40 percentage of participants Interval 22.7 to 59.4	11.8 percentage of participants Interval 1.5 to 36.4

SECONDARY outcome

Timeframe: 6 months from treatment initiation

Best overall response is defined as the best response across all time points (RECIST v1.1). The best overall response is determined once all the data for the participant is known. Each patient has been assigned one of the following categories (RECIST 1.1): complete response (disappearance of all target lesions); partial response (\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); progression (20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and stable disease (nor CR, PR or progression).

Outcome measures

Outcome measures
Measure	Stratum 1: Advanced Leiomyosarcoma n=13 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced Osteosarcoma n=15 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas n=9 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature n=30 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. n=17 Participants Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously . Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. Complete response (CR)	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. Partial response (PR)	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	6.7 percentage of participants Interval 0.2 to 32.0	0 percentage of participants Interval 0.0 to 0.0	26.7 percentage of participants Interval 12.3 to 45.9	5.9 percentage of participants Interval 0.2 to 28.7
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. Stable disease (SD)	23.1 percentage of participants Interval 5.0 to 53.8	35.7 percentage of participants Interval 12.8 to 64.9	35.7 percentage of participants Interval 12.8 to 64.9	33.3 percentage of participants Interval 11.8 to 61.6	33.3 percentage of participants Interval 7.5 to 70.1	36.7 percentage of participants Interval 19.9 to 56.1	23.5 percentage of participants Interval 6.8 to 49.9
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. Progression (PD)	76.9 percentage of participants Interval 46.2 to 95.0	50.0 percentage of participants Interval 23.0 to 77.0	57.1 percentage of participants Interval 28.9 to 82.3	53.3 percentage of participants Interval 26.6 to 78.7	66.7 percentage of participants Interval 29.9 to 92.5	33.3 percentage of participants Interval 17.3 to 52.8	70.6 percentage of participants Interval 44.0 to 89.7
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. Not evaluable for response (NE)	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 1.8 to 42.8	7.1 percentage of participants Interval 0.2 to 33.9	6.7 percentage of participants Interval 0.2 to 32.0	0 percentage of participants Interval 0.0 to 0.0	3.3 percentage of participants Interval 0.1 to 17.2	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From start of treatment, and during treatment until progression or death for any cause, whichever occurs first, for up to 12 months.

Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. Progressive disease defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Patients alive and progression free were censored at the date of last follow-up, death, or last patient contact. Progression is assessed as per RECIST v1.1. Progression-free survival is estimated as a function of time using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Stratum 1: Advanced Leiomyosarcoma n=13 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced Osteosarcoma n=15 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas n=9 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature n=30 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. n=17 Participants Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously . Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Median Progression-free Survival	1.4 months Interval 1.2 to 1.4	1.3 months Interval 1.1 to 2.9	1.4 months Interval 0.9 to 4.0	1.4 months Interval 1.0 to 1.4	1.4 months Interval 0.9 to 5.3	4.1 months Interval 1.4 to 12.5	1.8 months Interval 1.5 to 4.1

SECONDARY outcome

Timeframe: From start of treatment, and during treatment until death for any cause for up to 30 months

Overall survival (OS) defined as the time from randomization to death (due to any cause). Patients alive were censored at the date of last follow-up or last patient contact. Overall survival was estimated as a function of time using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Stratum 1: Advanced Leiomyosarcoma n=13 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=14 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced Osteosarcoma n=15 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas n=9 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature n=30 Participants Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. n=17 Participants Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously . Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP and G100: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously (200mg in 30 minutes -5 min/+10 min) and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Median Overall Survival	15.1 months Interval 4.4 to 17.9	6.7 months Interval 3.2 to 20.0	7.1 months Interval 2.0 to 16.3	5.6 months Interval 2.1 to 12.1	NA months The median overall survival was not reached, as fewer than 50% of patients had experienced the event at the time of analysis.	18.3 months Interval 8.5 to The median overall survival was estimated at 18.3 months (95% CI: 8.5 - NA). The upper bound of the confidence interval could not be determined due to an insufficient number of deaths occurring after the median time	25.2 months Interval 8.5 to The median overall survival was 25.2 months. The upper bound of the confidence interval could not be estimated (noted as "NR" for "Not Reached") due to the limited number of events after the median and the small sample size.

Adverse Events

Stratum 1: Advanced Leiomyosarcoma

Serious events: 5 serious events

Other events: 15 other events

Deaths: 13 deaths

Stratum 2: Advanced Undifferentiated Sarcoma

Serious events: 10 serious events

Other events: 16 other events

Deaths: 14 deaths

Stratum 3: Advanced Other Sarcoma

Serious events: 9 serious events

Other events: 16 other events

Deaths: 7 deaths

Stratum 4: Advanced GIST

Serious events: 12 serious events

Other events: 16 other events

Deaths: 12 deaths

Stratum 5: Advanced Soft-tissue Sarcomas

Serious events: 9 serious events

Other events: 10 other events

Deaths: 3 deaths

Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature

Serious events: 14 serious events

Other events: 35 other events

Deaths: 15 deaths

Stratum 7: Metastatic Soft-tissue Sarcoma.

Serious events: 8 serious events

Other events: 19 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Stratum 1: Advanced Leiomyosarcoma n=15 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=16 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced undifferentiated sarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=16 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced other sarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced GIST n=16 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced GIST. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas n=10 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced soft-tissue sarcomas. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature n=35 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced soft-tissue sarcomas with immune signature. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. n=19 participants at risk Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously. Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Blood and lymphatic system disorders Anemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Cardiac disorders Atrial fibrillation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Ascites	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Diarrhea	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Gastric perforation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Vomiting	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Death NOS	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Fever	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders General disorders and administration site conditions	13.3% 2/15 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Localized edema	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Hepatobiliary disorders Hepatic hemorrhage	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Immune system disorders Allergic reaction	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Anorectal infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Bronchial infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Hepatic infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Spesis	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Urinary tract infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Injury, poisoning and procedural complications Fracture	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Alkaline phosphatase increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations CPK increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Lymphocytes count decreased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Neutrophil count decreased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations White blood cell decreased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Anorexia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specif	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	13.3% 2/15 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Edema cerebral	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Nervous system disorders - Other, specify	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Seizure	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Urinary retention	6.7% 1/15 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Hematoma	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.

Other adverse events

Other adverse events
Measure	Stratum 1: Advanced Leiomyosarcoma n=15 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 2: Advanced Undifferentiated Sarcoma n=16 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced undifferentiated sarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 3: Advanced Other Sarcoma n=16 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced other sarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 4: Advanced GIST n=16 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced GIST. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 5: Advanced Soft-tissue Sarcomas n=10 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced soft-tissue sarcomas. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature n=35 participants at risk Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced soft-tissue sarcomas with immune signature. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.	Stratum 7: Metastatic Soft-tissue Sarcoma. n=19 participants at risk Treatment strategy B: Combination of MK3475 with Metronomic CP and G100. MK3475 will be administered intravenously. Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection. Combination of MK3475 with Metronomic CP: Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Cardiac disorders Lymph node pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Blood and lymphatic system disorders Anemia	20.0% 3/15 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	56.2% 9/16 • Number of events 11 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	22.9% 8/35 • Number of events 8 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	26.3% 5/19 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Cardiac disorders Atrial fibrillation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Cardiac disorders Atrial flutter	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Cardiac disorders Mitral valve disease	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Cardiac disorders Sinus tachycardia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Ear and labyrinth disorders Hearing impaired	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Ear and labyrinth disorders Tinnitus	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Ear and labyrinth disorders Vertigo	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Endocrine disorders Hyperthyroidism	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Endocrine disorders Hypothyroidism	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	22.9% 8/35 • Number of events 8 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Eye disorders Conjonctivitis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Eye disorders Dry eye	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Eye disorders Watering eyes	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	40.0% 4/10 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 7/35 • Number of events 8 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	15.8% 3/19 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Ascites	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Bloating	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Colitis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Constipation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	17.1% 6/35 • Number of events 6 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	15.8% 3/19 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Chill	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Dental caries	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Diarrhea	20.0% 3/15 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	31.2% 5/16 • Number of events 9 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	28.6% 10/35 • Number of events 11 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	26.3% 5/19 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Dyspepsia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Dry mouth	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Gingival pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Hemorrhoids	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Mucositis oral	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	30.0% 3/10 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 6 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	37.1% 13/35 • Number of events 13 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	47.4% 9/19 • Number of events 9 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Toothache	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Gastrointestinal disorders Vomiting	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	21.1% 4/19 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Edema limbs	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Fatigue	73.3% 11/15 • Number of events 12 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	43.8% 7/16 • Number of events 7 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	68.8% 11/16 • Number of events 13 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	50.0% 8/16 • Number of events 9 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	90.0% 9/10 • Number of events 10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	65.7% 23/35 • Number of events 24 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	52.6% 10/19 • Number of events 10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Fever	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	30.0% 3/10 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Flu like symptoms	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Gait disturbance	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Localized edema	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Malaise	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	15.8% 3/19 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Non-cardiac chest pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
General disorders Pain	6.7% 1/15 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	37.5% 6/16 • Number of events 7 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Hepatobiliary disorders Hepatobiliary disorders - Other, specifiy	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Immune system disorders Allergic reaction	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Immune system disorders Anaphylaxis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Immune system disorders Autoimmune disorder	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Immune system disorders Immune system disorders - Other, specify	26.7% 4/15 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Bronchial infection	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Catheter related infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	14.3% 5/35 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Lip infection	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Meningitis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Pharyngitis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Rhinitis infective	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Skin infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Tooth infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Upper respiratory infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Urinary tract infection	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Infections and infestations Wound infection	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Injury, poisoning and procedural complications Fracture	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Injury, poisoning and procedural complications Postoperative hemorrhage	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Alanine aminotransferase increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	17.1% 6/35 • Number of events 8 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	15.8% 3/19 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Alkaline phosphatase increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	30.0% 3/10 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Aspartate aminotransferase increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	21.1% 4/19 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Blood bilirubin increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations CPK increase	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Creatinine increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations GGT increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	40.0% 4/10 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Investigations - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	14.3% 5/35 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Dizziness	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Lipase increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Lymphocyte count decreased	13.3% 2/15 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	45.7% 16/35 • Number of events 16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	36.8% 7/19 • Number of events 7 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Lymphocyte count increased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Neutrophil count decreased	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Platelet count decreased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations Weight loss	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Investigations White blood cell decreased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Anorexia	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	37.5% 6/16 • Number of events 6 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	40.0% 4/10 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 5/15 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Musculoskeletal and connective tissue disorders Back pain	20.0% 3/15 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Musculoskeletal and connective tissue disorders Myalgia	26.7% 4/15 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	17.1% 6/35 • Number of events 7 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	52.6% 10/19 • Number of events 12 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Dysesthesia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Dysgeusia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Headache	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Nervous system disorders - Ohter, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Neuralgia	13.3% 2/15 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Paresthesia	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Phantom pain	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Nervous system disorders Somnolence	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Psychiatric disorders Anxiety	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Psychiatric disorders Confusion	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Psychiatric disorders Depression	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Psychiatric disorders Insomnia	13.3% 2/15 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Psychiatric disorders Libido decreased	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Acute kidney disease	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Acute kidney injury	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Chronic kidney disease	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Cystitis noninfective	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Hematuria	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Proteinuria	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Urinary frequency	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Urinary incontinence	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Reproductive system and breast disorders Menorrhagia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Hypertension	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Reproductive system and breast disorders Pelvic pain	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	20.0% 2/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Hypotension	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	31.2% 5/16 • Number of events 6 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	8.6% 3/35 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	12.5% 2/16 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Respiratory, thoracic and mediastinal disorders Sinus disorders	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.7% 2/35 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Hyperrhidrosis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Pruritus	13.3% 2/15 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 4 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	31.6% 6/19 • Number of events 6 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	25.0% 4/16 • Number of events 5 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	18.8% 3/16 • Number of events 3 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	11.4% 4/35 • Number of events 6 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.5% 2/19 • Number of events 2 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Hot flashes	6.7% 1/15 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	5.3% 1/19 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Lymphedema	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	2.9% 1/35 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Phlebitis	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Thromboembolic event	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	10.0% 1/10 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/15 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	6.2% 1/16 • Number of events 1 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/16 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/10 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/35 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.	0.00% 0/19 • Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months. Safety population: All patients with at least one treatment (any) administration.

Additional Information

Pr Antoine Italiano

Institut Bergonie

Phone: 0524071947

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place