Trial Outcomes & Findings for A Study of TAS-120 in Patients With Metastatic Breast Cancer (NCT NCT04024436)

NCT ID: NCT04024436

Last Updated: 2025-11-13

Results Overview

ORR was defined as the percentage of participants with a confirmed response of either complete response (CR) or partial response (PR), based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: At the end of every 2 cycles until disease progression (up to 40 months)
• Results posted on: 2025-11-13

Participant Flow

Participants took part in the study from 28 January 2020 to 06 September 2023.

A total of 64 participants were enrolled in either Cohorts 1, 2 or 3 to receive futibatinib or to Cohort 4 to receive futibatinib plus fulvestrant.

Participant milestones

Measure	Futibatinib (Cohort 1) Participants with advanced or metastatic hormone receptor - positive (HR+), human epidermal growth factor receptor 2 - negative (HER2-) breast cancer, harboring fibroblast growth factor receptor 2 (FGFR2) gene amplification, with measurable disease received futibatinib, 20 milligrams (mg), oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days.	Futibatinib (Cohort 2) Participants with advanced or metastatic triple negative breast cancer (TNBC), harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib (Cohort 3) Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Overall Study STARTED	17	21	4	22
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	17	21	4	22

Reasons for withdrawal

Measure	Futibatinib (Cohort 1) Participants with advanced or metastatic hormone receptor - positive (HR+), human epidermal growth factor receptor 2 - negative (HER2-) breast cancer, harboring fibroblast growth factor receptor 2 (FGFR2) gene amplification, with measurable disease received futibatinib, 20 milligrams (mg), oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days.	Futibatinib (Cohort 2) Participants with advanced or metastatic triple negative breast cancer (TNBC), harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib (Cohort 3) Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Overall Study Death	10	14	2	7
Overall Study Loss to follow up	1	0	0	1
Overall Study Withdrawal of consent	2	0	0	1
Overall Study Study termination by sponsor	4	6	2	11
Overall Study Reason Not Specified	0	1	0	2

Baseline Characteristics

A Study of TAS-120 in Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Futibatinib (Cohort 1) n=17 Participants Participants with advanced or metastatic HR+, HER2- breast cancer, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days	Futibatinib (Cohort 2) n=21 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib (Cohort 3) n=4 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=22 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Total n=64 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 11.42 • n=10 Participants	51.4 years STANDARD_DEVIATION 14.50 • n=10 Participants	60.8 years STANDARD_DEVIATION 5.74 • n=20 Participants	52.7 years STANDARD_DEVIATION 12.68 • n=45 Participants	54.7 years STANDARD_DEVIATION 13.01 • n=44 Participants
Sex: Female, Male Female	17 Participants n=10 Participants	21 Participants n=10 Participants	4 Participants n=20 Participants	22 Participants n=45 Participants	64 Participants n=44 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants	4 Participants n=44 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=10 Participants	15 Participants n=10 Participants	4 Participants n=20 Participants	13 Participants n=45 Participants	47 Participants n=44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	5 Participants n=10 Participants	0 Participants n=20 Participants	7 Participants n=45 Participants	13 Participants n=44 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Asian	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants	2 Participants n=44 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants
Race (NIH/OMB) Black or African American	2 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants	4 Participants n=44 Participants
Race (NIH/OMB) White	14 Participants n=10 Participants	12 Participants n=10 Participants	4 Participants n=20 Participants	16 Participants n=45 Participants	46 Participants n=44 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	7 Participants n=10 Participants	0 Participants n=20 Participants	4 Participants n=45 Participants	11 Participants n=44 Participants

PRIMARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 1 and 2 as pre-specified in Protocol and SAP.

ORR was defined as the percentage of participants with a confirmed response of either complete response (CR) or partial response (PR), based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Futibatinib (Cohort 3) n=17 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) n=21 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Objective Response Rate (ORR) - Cohorts 1, 2	0 percentage of participants Interval 0.0 to 19.5	9.5 percentage of participants Interval 1.2 to 30.4	—	—

PRIMARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 3 as pre-specified in Protocol and SAP.

CBR was defined as the percentage of participants with a confirmed response of CR or stable disease (SD) lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest

Outcome measures

Measure	Futibatinib (Cohort 3) n=4 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Clinical Benefit Rate (CBR) - Cohort 3	50.0 percentage of participants Interval 6.8 to 93.2	—	—	—

PRIMARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 6 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP.

The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Futibatinib (Cohort 3) n=22 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
6-month Progression-free Survival (PFS) Rate - Cohort 4	45.5 percentage of participants Interval 24.4 to 67.8	—	—	—

SECONDARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 3 as pre-specified in Protocol and SAP.

CR rate was defined as the percentage of participants who achieved CR. CR was defined as disappearance of all targets. Any pathological lymph node must have reduction in short axis to <10 mm. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Futibatinib (Cohort 3) n=4 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Complete Response (CR) Rate - Cohort 3	0 percentage of participants Interval 0.0 to 60.2	—	—	—

SECONDARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP.

ORR was defined as the percentage of participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Futibatinib (Cohort 3) n=22 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Overall Response Rate (ORR) - Cohort 4	18.2 percentage of participants Interval 5.2 to 40.3	—	—	—

SECONDARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohorts 1, 2 and 4 as pre-specified in Protocol and SAP.

CBR was defined as the percentage of participants with a confirmed response of CR, PR or SD lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Futibatinib (Cohort 3) n=17 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) n=21 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=22 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Clinical Benefit Rate (CBR) - Cohort 1,2, and 4	11.8 percentage of participants Interval 1.5 to 36.4	23.8 percentage of participants Interval 8.2 to 47.2	50.0 percentage of participants Interval 28.2 to 71.8	—

SECONDARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 6 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohorts 1, 2 and 3 as pre-specified in Protocol and SAP.

The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Measure	Futibatinib (Cohort 3) n=17 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) n=21 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=4 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
6-month PFS Rate - Cohorts 1,2, and 3	5.9 percentage of participants Interval 0.1 to 28.7	19.0 percentage of participants Interval 5.4 to 41.9	50.0 percentage of participants Interval 6.8 to 93.2	—

SECONDARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug.

PFS was defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression based on investigator assessment, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.

Outcome measures

Measure	Futibatinib (Cohort 3) n=17 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) n=21 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=4 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=22 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Progression Free Survival (PFS)	3.7 months Interval 1.7 to 5.1	1.9 months Interval 1.6 to 4.0	12.4 months Interval 1.9 to Upper limit of 95% CI was not estimable due to a lack of sufficient number of events within the cohort to estimate the parameter.	7.2 months Interval 2.1 to 7.6

SECONDARY outcome

Timeframe: At the end of every 2 cycles until disease progression (up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. Overall number of participants analyzed is the number of participants with data available for analysis.

DOR was defined as the time from the first documentation of objective response to the to the date of death (any cause) or disease progression, based on Investigator assessment, whichever occurs first. Objective response was defined as participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Futibatinib (Cohort 3) Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) n=2 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=4 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Duration of Response (DOR)	—	3.38 months Interval 3.1 to 3.7	—	6.34 months Interval 3.3 to 16.7

SECONDARY outcome

Timeframe: Up to 40 months

Population: All treated population included all enrolled participants who received at least 1 dose of study drug.

OS was defined as the time (in months) from the date of first dose of the study drug to the date of death. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure.

Outcome measures

Measure	Futibatinib (Cohort 3) n=17 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) n=21 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=4 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=22 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Overall Survival (OS)	16.5 months Interval 8.1 to Upper limit of 95% CI was not estimable due to a lack of sufficient number of events within the cohort to estimate the parameter.	10.2 months Interval 6.1 to 21.8	30.4 months Interval 12.4 to Upper limit of 95% CI was not estimable due to a lack of sufficient number of events within the cohort to estimate the parameter.	23.9 months Interval 20.6 to Upper limit of 95% CI was not estimable due to a lack of sufficient number of events within the cohort to estimate the parameter.

SECONDARY outcome

Timeframe: From the first dose of study drug up to 30 days after the last dose (Up to 40 months)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug.

An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug.

Outcome measures

Measure	Futibatinib (Cohort 3) n=17 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) n=21 Participants Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=4 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=22 Participants Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Number of Participants With Adverse Events (AEs)	17 Participants	21 Participants	4 Participants	22 Participants

SECONDARY outcome

Timeframe: Cycle 1 (cycle length= 28 days)

Population: All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP.

A DLT was defined as any AE that occurs during Cycle 1 that is not clearly attributable to an extraneous cause, such as an underlying disease, occurring in Cycle 1, and meeting at least one of the criteria defined in the protocol. An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug.

Outcome measures

Measure	Futibatinib (Cohort 3) n=22 Participants Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib (Cohort 2) Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.	Futibatinib Plus Fulvestrant (Cohort 4) Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Number of Participants With Dose Limiting Toxicities (DLTs) - Cohort 4	0 Participants	—	—	—

Adverse Events

Futibatinib (Cohort 1)

Serious events: 4 serious events

Other events: 16 other events

Deaths: 10 deaths

Futibatinib (Cohort 2)

Serious events: 5 serious events

Other events: 21 other events

Deaths: 14 deaths

Futibatinib (Cohort 3)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Futibatinib Plus Fulvestrant (Cohort 4)

Serious events: 4 serious events

Other events: 22 other events

Deaths: 7 deaths

Serious adverse events

Measure	Futibatinib (Cohort 1) n=17 participants at risk Participants with advanced or metastatic HR+, HER2- breast cancer, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days.	Futibatinib (Cohort 2) n=21 participants at risk Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib (Cohort 3) n=4 participants at risk Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=22 participants at risk Participants with advanced or metastatic HR+ HER2-, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Gastrointestinal disorders Nausea	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Volvulus	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute promyelocytic leukaemia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic ischaemia	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Ischaemic stroke	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Hepatic encephalopathy	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.

Other adverse events

Measure	Futibatinib (Cohort 1) n=17 participants at risk Participants with advanced or metastatic HR+, HER2- breast cancer, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days.	Futibatinib (Cohort 2) n=21 participants at risk Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days.	Futibatinib (Cohort 3) n=4 participants at risk Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.	Futibatinib Plus Fulvestrant (Cohort 4) n=22 participants at risk Participants with advanced or metastatic HR+ HER2-, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days.
Metabolism and nutrition disorders Hyperkalaemia	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	47.1% 8/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	42.9% 9/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	59.1% 13/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	23.5% 4/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	38.1% 8/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	45.5% 10/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	76.5% 13/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	85.7% 18/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	75.0% 3/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	95.5% 21/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	19.0% 4/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	31.8% 7/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	17.6% 3/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	41.2% 7/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	28.6% 6/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	40.9% 9/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	29.4% 5/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	19.0% 4/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	45.5% 10/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	19.0% 4/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	31.8% 7/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	17.6% 3/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	18.2% 4/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	18.2% 4/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	22.7% 5/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dysphagia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oral pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oral dysaesthesia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	41.2% 7/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	23.8% 5/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	50.0% 11/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	23.5% 4/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	59.1% 13/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Weight decreased	23.5% 4/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	19.0% 4/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	27.3% 6/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	27.3% 6/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Blood bilirubin increased	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood creatinine increased	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations White blood cell count decreased	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood cholesterol increased	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood phosphorus increased	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood triglycerides increased	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Gamma-glutamyltransferase increased	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Investigations Computerised tomogram abnormal	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	23.5% 4/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	59.1% 13/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	17.6% 3/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	28.6% 6/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	22.7% 5/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	22.7% 5/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Onycholysis	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	17.6% 3/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Nail disorder	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Nail discolouration	17.6% 3/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pain of skin	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermal cyst	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Onychomadesis	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	19.0% 4/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	31.8% 7/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	17.6% 3/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	18.2% 4/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	19.0% 4/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	18.2% 4/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Groin pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	22.7% 5/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Headache	23.5% 4/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Taste disorder	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Seizure	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Tremor	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Epilepsy	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Migraine	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Parosmia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Peripheral motor neuropathy	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
General disorders Fatigue	23.5% 4/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	33.3% 7/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	75.0% 3/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	31.8% 7/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
General disorders Mucosal inflammation	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	14.3% 3/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
General disorders Malaise	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Dry eye	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	23.8% 5/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	50.0% 2/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	31.8% 7/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Ocular hyperaemia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Vision blurred	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Conjunctival hyperaemia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Vitreous floaters	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Central serous chorioretinopathy	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Corneal disorder	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Eye pain	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Eye disorders Growth of eyelashes	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	23.5% 4/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	23.8% 5/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	13.6% 3/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymph node pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	11.8% 2/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Eye infection	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.5% 2/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Erysipelas	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Herpes simplex reactivation	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Hordeolum	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Oropharyngeal pain	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.8% 1/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	9.1% 2/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Vascular disorders Hot flush	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	4.5% 1/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	25.0% 1/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Confusional state	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.
Psychiatric disorders Sleep disorder	5.9% 1/17 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/21 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/4 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/22 • From the first dose of study drug up to 30 days after the last dose (Up to 40 months) All treated population included all enrolled participants who received at least 1 dose of study drug.

Additional Information

Taiho Oncology, Inc

Taiho Oncology, Inc

Phone: +1 844-878-2446

Email: medicalinformation@taihooncology.com

Results disclosure agreements

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

Restriction type: OTHER