Trial Outcomes & Findings for Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma (NCT NCT04604132)

NCT ID: NCT04604132

Last Updated: 2024-04-04

Results Overview

ORR was defined by the percentage of patients with confirmed complete response (CR, which means disappearance of all target lesions) or partial response (PR, which means \>=30% decrease in the sum of the longest diameter of target lesions) by blinded independent central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST 1.1). Overall Response (OR) = CR + PR. The patients in Cohort 1.1 had FGFR2 fusions or amplification gastric adenocarcinoma (GAC) and FGFR1-3 mutations GAC in Cohort 1.2.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: From first dose and up to 18 months
• Results posted on: 2024-04-04

Participant Flow

From 6 Oct. 2020 to 10 Jun. 2022, 919 patients (pt.) had molecular pre-screening. 66 had clinical screening, and 47 were treated. In Substudy 2, pt. were allocated to 1 of 3 dose levels using a dose escalation scheme: Derazantinib at a dose of 200 mg once daily, 300 mg once daily, or 200 mg twice daily, all in combination with paclitaxel and ramucirumab. However, no pt. received the highest dose, therefore only the 200 and 300 mg once daily dose levels are presented in the results section.

Participant milestones

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.	Substudy 2: Derazantinib 300 mg Once Daily + Paclitaxel + Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Overall Study STARTED	13	8	13	6	7
Overall Study COMPLETED	0	0	0	0	1
Overall Study NOT COMPLETED	13	8	13	6	6

Reasons for withdrawal

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.	Substudy 2: Derazantinib 300 mg Once Daily + Paclitaxel + Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Overall Study Adverse Event	2	0	0	1	2
Overall Study Study terminated by sponsor	0	0	0	0	1
Overall Study Progressive disease: Clinical progression	0	0	1	0	0
Overall Study Progressive disease: Radiological progression	8	7	10	4	3
Overall Study Death	3	1	2	1	0

Baseline Characteristics

Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma

Baseline characteristics by cohort

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=8 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily n=13 Participants Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab n=6 Participants Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.	Substudy 2: Derazantinib 300 mg Once Daily+Paclitaxel+ Ramucirumab n=7 Participants Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.	Total n=47 Participants Total of all reporting groups
Age, Continuous	65.5 years STANDARD_DEVIATION 10.77 • n=5 Participants	66.1 years STANDARD_DEVIATION 9.39 • n=7 Participants	54.8 years STANDARD_DEVIATION 13.43 • n=5 Participants	55.2 years STANDARD_DEVIATION 10.53 • n=4 Participants	52.0 years STANDARD_DEVIATION 11.34 • n=21 Participants	59.3 years STANDARD_DEVIATION 12.43 • n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	14 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	33 Participants n=8 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=8 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	36 Participants n=8 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: From first dose and up to 18 months

Population: Modified intent-to-treat (mITT) population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

ORR was defined by the percentage of patients with confirmed complete response (CR, which means disappearance of all target lesions) or partial response (PR, which means >=30% decrease in the sum of the longest diameter of target lesions) by blinded independent central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST 1.1). Overall Response (OR) = CR + PR.

The patients in Cohort 1.1 had FGFR2 fusions or amplification gastric adenocarcinoma (GAC) and FGFR1-3 mutations GAC in Cohort 1.2.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=8 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Objective Response Rate (ORR) in Substudy 1 (in Cohorts 1.1 and 1.2)	0.0 Percentage of participants Interval 0.0 to 20.6	0.0 Percentage of participants Interval 0.0 to 31.2	—	—	—

PRIMARY outcome

Timeframe: From first dose and up to 4 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

PFS4 was defined by the percentage of patients alive and free of disease progression (defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) by BICR per RECIST. 1.1. Patients in this Cohort had FGFR fusions, amplifications or mutations GAC

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Progression-free Survival at 4 Months (PFS4) in Substudy 1 in Cohort 1.3	7.7 Percentage of participants Interval 0.4 to 31.6	—	—	—	—

PRIMARY outcome

Timeframe: From first dose and up to 18 months

Population: The Maximum Tolerated Dose (MTD)-determining population comprised all patients enrolled in Substudy 2 who meet the minimum criteria during the first 28-day treatment cycle (Cycle 1): * received at least one dose of derazantinib-paclitaxel-ramucirumab in combination and has experienced a DLT * or * received ≥ 80% of the derazantinib-paclitaxel-ramucirumab dose, respectively, in Cycle 1 and, had been observed for ≥ 28 days following the first dose, and had been evaluated for safety.

RP2D was determined from safety and tolerability according to the aggregate of dose-limiting toxicity criteria and adverse event (AE) data, and considering further pharmacokinetic and efficacy data of the derazantinib-paclitaxel-ramucirumab combination in patients with FGFR fusions, amplifications or mutations GAC.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Recommended Phase 2 Dose (RP2D) in Substudy 2 (Derazantinib-paclitaxel-ramucirumab in Combination)	200 mg	—	—	—	—

SECONDARY outcome

Timeframe: From first dose and up to 9 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

ORR was defined by the percentage of patients with CR or PR by BICR according to RECIST Version 1.1.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
ORR in Substudy 1 in Cohort 1.3	0.0 Percentage of participants Interval 0.0 to 20.6	—	—	—	—

SECONDARY outcome

Timeframe: From first dose and up to 18 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

Defined as the percentage of patients with confirmed CR, PR or stable disease (SD) by BICR per RECIST version 1.1.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=8 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily n=13 Participants Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily n=34 Participants Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Disease Control Rate (DCR) in Substudy 1: Cohort 1.1, 1.2 and 1.3 and Combined Cohorts	30.8 Percentage of participants Interval 11.3 to 57.3	25.0 Percentage of participants Interval 4.6 to 60.0	15.4 Percentage of participants Interval 2.8 to 41.0	23.5 Percentage of participants Interval 12.3 to 38.5	—

SECONDARY outcome

Timeframe: From first dose and up to 9 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

PFS was calculated from patient enrollment to progressive disease (PD) date by BICR per RECIST version 1.1

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
PFS in Substudy 1 in Cohort 1.3	1.7 months Interval 1.0 to 1.9	—	—	—	—

SECONDARY outcome

Timeframe: From first dose and up to 9 months

Population: The intent-to-treat (ITT) population comprised all patients enrolled and allocated to treatment, regardless of the administration of the study treatment.

OS was measured from patient enrollment to time of death.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Overall Survival (OS) in Substudy 1 in Cohort 1.3	3.3 months Interval 2.2 to 3.7	—	—	—	—

SECONDARY outcome

Timeframe: From first dose and up to 15 months

Population: ITT population comprised all patients enrolled and allocated to treatment, regardless of the administration of the study treatment.

OS was measured from patient enrollment to time of death

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=6 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=7 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
OS in Substudy 2	5.5 months Interval 2.7 to Not evaluable due to the low number of events.	NA months Not evaluable due to the low number of events.	—	—	—

SECONDARY outcome

Timeframe: From first dose and up to 15 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

ORR was defined by the percentage of patients with CR or PR by BICR per RECIST version 1.1.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=5 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=7 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
ORR in Substudy 2	40.0 Percentage of participants Interval 7.6 to 81.1	57.1 Percentage of participants Interval 22.5 to 87.1	—	—	—

SECONDARY outcome

Timeframe: From first dose and up to 15 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

Defined as the percentage of patients with confirmed CR, PR or SD by BICR per RECIST version 1.1.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=5 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=7 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily n=12 Participants Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
DCR in Substudy 2	80.0 Percentage of participants Interval 34.3 to 99.0	71.4 Percentage of participants Interval 34.1 to 94.7	75.0 Percentage of participants Interval 47.3 to 92.8	—	—

SECONDARY outcome

Timeframe: From first dose and up to 15 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive). Within the mITT, only patients with confirmed CR or PR have been considered for this endpoint (2 and 4 patients from the 200 mg and 300 mg arm, respectively)

DOR was calculated from the first date of documented tumor response to disease progression by BICR per RECIST version 1.1 (or death if no documentation of PD is obtained).

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=2 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=4 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily n=6 Participants Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
DOR in Substudy 2 (Separate and Combined Cohorts)	9.2 months Only a low number of patients with CR or PR (2 patients) and low number of related events (high number of censoring and time of censoring) could be considered for the evaluation. As such, some parameters are impossible to be estimated or to be evaluated by the statistical method used (Kaplan-Meier).	NA months Interval 3.3 to Only a low number of patients with CR or PR (4 patients) and low number of related events (high number of censoring and time of censoring) could be considered for the evaluation. As such, some parameters are impossible to be estimated or to be evaluated by the statistical method used (Kaplan-Meier).	9.2 months Interval 3.3 to Only a low number of patients with CR or PR (2 and 4 patients from the 200 mg and 300 mg arm, respectively) and low number of related events (high number of censoring and time of censoring) could be considered for the evaluation. As such, some parameters are impossible to be estimated or to be evaluated by the statistical method used (Kaplan-Meier).	—	—

SECONDARY outcome

Timeframe: From first dose and up to 15 months

Population: mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).

PFS was calculated from patient enrollment to progressive disease (PD) date by BICR per RECIST version 1.1.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=5 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=7 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
PFS in Substudy 2	11.1 months Interval 1.6 to Not evaluable due to the low number of events.	NA months Interval 1.7 to Not evaluable due to the low number of events.	—	—	—

SECONDARY outcome

Timeframe: TEAEs defined as AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months

Population: The Safety population comprises all patients who received at least one dose of study treatment (derazantinib, paclitaxel or ramucirumab).

Number of patients experiencing TEAE of Grade 3 and above according to Common Terminology Criteria for Adverse Events (CTCAE). CTCAE are a set of criteria for the standardized classification of TEAEs of drugs used in cancer therapy. It uses a range of grades from 1 to 5 describing increasing levels of severity of the TEAEs.

Outcome measures

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=8 Participants Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily n=13 Participants Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.	Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily n=6 Participants Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab n=7 Participants Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab. Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Number of Patients With at Least Grade 3 Treatment-emergent Adverse Events (TEAEs) Number of patients with only unrelated TEAEs of Grade 3 or above	9 Counts of participants	3 Counts of participants	5 Counts of participants	1 Counts of participants	1 Counts of participants
Number of Patients With at Least Grade 3 Treatment-emergent Adverse Events (TEAEs) Number of patients with related TEAEs of Grade 3 or above	0 Counts of participants	3 Counts of participants	6 Counts of participants	4 Counts of participants	6 Counts of participants
Number of Patients With at Least Grade 3 Treatment-emergent Adverse Events (TEAEs) Number of patients without TEAEs of Grade 3 or above	4 Counts of participants	2 Counts of participants	2 Counts of participants	1 Counts of participants	0 Counts of participants

Adverse Events

Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily

Serious events: 7 serious events

Other events: 12 other events

Deaths: 10 deaths

Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily

Serious events: 4 serious events

Other events: 8 other events

Deaths: 6 deaths

Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily

Serious events: 10 serious events

Other events: 13 other events

Deaths: 10 deaths

Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 participants at risk Patients with FGFR2 fusions or amplifications were treated with 300 mg Derazantinib monotherapy once daily	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=8 participants at risk Patients with FGFR1-3 mutations were treated with 300 mg Derazantinib monotherapy once daily	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily n=13 participants at risk Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib monotherapy twice daily	Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab n=6 participants at risk Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab n=7 participants at risk Patients with FGFR fusions, amplifications or mutations were treated with 300 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Cardiac disorders Acute coronary syndrome	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Blood and lymphatic system disorders Anaemia	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Encephalopathy	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Anal haemorrhage	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Stomatitis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations COVID-19 pneumonia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Pneumonia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Sepsis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Asthenia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Disease progression	23.1% 3/13 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	25.0% 2/8 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	46.2% 6/13 • Number of events 6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	50.0% 3/6 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders General physical health deterioration	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Pyrexia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Hepatobiliary disorders Hepatic failure	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).

Other adverse events

Measure	Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily n=13 participants at risk Patients with FGFR2 fusions or amplifications were treated with 300 mg Derazantinib monotherapy once daily	Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily n=8 participants at risk Patients with FGFR1-3 mutations were treated with 300 mg Derazantinib monotherapy once daily	Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily n=13 participants at risk Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib monotherapy twice daily	Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab n=6 participants at risk Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.	Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab n=7 participants at risk Patients with FGFR fusions, amplifications or mutations were treated with 300 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab Paclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab. Ramucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.
Gastrointestinal disorders Odynophagia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Stomatitis	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Vomiting	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	37.5% 3/8 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	30.8% 4/13 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Renal and urinary disorders Proteinuria	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	42.9% 3/7 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Gingival swelling	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Haemorrhoids	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Melaena	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Nausea	38.5% 5/13 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	50.0% 4/8 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	46.2% 6/13 • Number of events 6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Alanine aminotransferase increased	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	25.0% 2/8 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	46.2% 6/13 • Number of events 6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	33.3% 2/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	71.4% 5/7 • Number of events 7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Amylase increased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Aspartate aminotransferase increased	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	25.0% 2/8 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	53.8% 7/13 • Number of events 9 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	50.0% 3/6 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	57.1% 4/7 • Number of events 7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood albumin decreased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood alkaline phosphatase increased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	38.5% 5/13 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood bilirubin increased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood creatinine increased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood glucose increased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood lactate dehydrogenase increased	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood phosphorus increased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Blood potassium increased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations C-reactive protein increased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Electrocardiogram QT prolonged	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Gamma-glutamyltransferase increased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Lipase increased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Neutrophil count decreased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 14 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Platelet count decreased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Platelet count increased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Protein total decreased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Transaminases increased	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Weight decreased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations Weight increased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Investigations White blood cell count decreased	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Cardiac disorders Cardiac failure	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Blood and lymphatic system disorders Anaemia	23.1% 3/13 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	50.0% 4/8 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	30.8% 4/13 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	50.0% 3/6 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	42.9% 3/7 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Blood and lymphatic system disorders Leukopenia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	33.3% 2/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	33.3% 2/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Blood and lymphatic system disorders Neutropenia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	66.7% 4/6 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	71.4% 5/7 • Number of events 15 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Dizziness	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Dysgeusia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Neuralgia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Neuropathy peripheral	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Neurotoxicity	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Nervous system disorders Syncope	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Eye disorders Diabetic retinopathy	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Eye disorders Dry eye	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Eye disorders Eyelid oedema	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Eye disorders Iridocyclitis	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Eye disorders Keratitis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Eye disorders Punctate keratitis	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Eye disorders Visual impairment	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Ear and labyrinth disorders Ear congestion	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	25.0% 2/8 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	33.3% 2/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	42.9% 3/7 • Number of events 6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Abdominal pain upper	23.1% 3/13 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Breath odour	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	30.8% 4/13 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	38.5% 5/13 • Number of events 6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	33.3% 2/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Dry mouth	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Dyspepsia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	30.8% 4/13 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Dysphagia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Erosive oesophagitis	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Faeces discoloured	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Flatulence	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Gastrointestinal disorders Gastritis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Muscle haemorrhage	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	23.1% 3/13 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Decreased appetite	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	25.0% 2/8 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	30.8% 4/13 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Hyperphosphataemia	23.1% 3/13 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	28.6% 2/7 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Hyperphosphatasaemia	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Hyperuricaemia	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Hypokalaemia	7.7% 1/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Bronchitis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations COVID-19	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Cytomegalovirus infection	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Gingivitis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Herpes virus infection	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Respiratory tract infection viral	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Vascular disorders Hypertension	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Vascular disorders Thrombophlebitis	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Asthenia	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	50.0% 4/8 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	42.9% 3/7 • Number of events 4 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Chest pain	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Chills	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Fatigue	15.4% 2/13 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	37.5% 3/8 • Number of events 3 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	38.5% 5/13 • Number of events 5 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	33.3% 2/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Feeling hot	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders General physical health deterioration	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Mucosal inflammation	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Oedema	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Oedema peripheral	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
General disorders Pyrexia	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	16.7% 1/6 • Number of events 2 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Hepatobiliary disorders Hepatotoxicity	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	12.5% 1/8 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Reproductive system and breast disorders Penile haemorrhage	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	7.7% 1/13 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/7 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).
Psychiatric disorders Insomnia	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/8 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/13 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	0.00% 0/6 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).	14.3% 1/7 • Number of events 1 • AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).

Additional Information

Manuel Häckl, MD

Basilea Pharmaceutica International Ltd, Allschwil

Phone: +41 76 302 53 10

Email: manuel.haeckl@basilea.com

Results disclosure agreements

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

Restriction type: GT60