Trial Outcomes & Findings for A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma (NCT NCT04187404)

NCT ID: NCT04187404

Last Updated: 2026-01-30

Results Overview

Incidences of treatment-emergent serious adverse events using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: 46 months maximum (from baseline up to study end)
• Results posted on: 2026-01-30

Participant Flow

Cohort 1 safety lead-in assessed safety and tolerability of EO2401 in combination with nivolumab during 4 weeks. Evaluable patients in Cohort 1 will be assessed as part of the planned Cohorts 2A (non-randomized) and 3A, respectively. The schedule of EO2401 and nivolumab administrations are the same in Cohorts 2A (non randomized) and Cohort 3A as in Cohort 1.

Participant milestones

Measure	Cohort 2A (Non-randomized) Cohort 2A includes patients (previously treated) with adrenocortical. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A are treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A will be treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A who will be treated by nivolumab alone.	Cohort 2B (Non-randomized) Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. EO2401 in combination with nivolumab
Overall Study STARTED	26	13	2	4	7	13	5
Overall Study Started and Originally Enrolled in Cohort 1 (Safety lead-in).	2	0	0	0	0	1	0
Overall Study COMPLETED	26	13	2	4	7	13	5
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma

Baseline characteristics by cohort

Measure	Cohort 2A (Non-randomized) n=26 Participants Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab.	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 Participants Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab.	Cohort 3A (Non-randomized) n=13 Participants Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 Participants Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Total n=70 Participants Total of all reporting groups
Age, Continuous	46 years n=35 Participants	54 years n=4328 Participants	49.5 years n=8687 Participants	52.5 years n=269 Participants	47 years n=530 Participants	55 years n=170 Participants	63 years n=7 Participants	51 years n=11 Participants
Sex: Female, Male Female	18 Participants n=35 Participants	10 Participants n=4328 Participants	0 Participants n=8687 Participants	3 Participants n=269 Participants	7 Participants n=530 Participants	4 Participants n=170 Participants	4 Participants n=7 Participants	46 Participants n=11 Participants
Sex: Female, Male Male	8 Participants n=35 Participants	3 Participants n=4328 Participants	2 Participants n=8687 Participants	1 Participants n=269 Participants	0 Participants n=530 Participants	9 Participants n=170 Participants	1 Participants n=7 Participants	24 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	1 Participants n=7 Participants	1 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=35 Participants	13 Participants n=4328 Participants	2 Participants n=8687 Participants	4 Participants n=269 Participants	7 Participants n=530 Participants	13 Participants n=170 Participants	4 Participants n=7 Participants	69 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Race (NIH/OMB) White	26 Participants n=35 Participants	13 Participants n=4328 Participants	2 Participants n=8687 Participants	4 Participants n=269 Participants	7 Participants n=530 Participants	13 Participants n=170 Participants	5 Participants n=7 Participants	70 Participants n=11 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Region of Enrollment Sweden	1 participants n=35 Participants	0 participants n=4328 Participants	0 participants n=8687 Participants	0 participants n=269 Participants	0 participants n=530 Participants	0 participants n=170 Participants	0 participants n=7 Participants	1 participants n=11 Participants
Region of Enrollment Netherlands	5 participants n=35 Participants	2 participants n=4328 Participants	1 participants n=8687 Participants	1 participants n=269 Participants	2 participants n=530 Participants	2 participants n=170 Participants	0 participants n=7 Participants	13 participants n=11 Participants
Region of Enrollment United States	0 participants n=35 Participants	0 participants n=4328 Participants	0 participants n=8687 Participants	1 participants n=269 Participants	0 participants n=530 Participants	1 participants n=170 Participants	1 participants n=7 Participants	3 participants n=11 Participants
Region of Enrollment Denmark	0 participants n=35 Participants	0 participants n=4328 Participants	0 participants n=8687 Participants	0 participants n=269 Participants	1 participants n=530 Participants	0 participants n=170 Participants	0 participants n=7 Participants	1 participants n=11 Participants
Region of Enrollment Italy	8 participants n=35 Participants	5 participants n=4328 Participants	1 participants n=8687 Participants	1 participants n=269 Participants	2 participants n=530 Participants	5 participants n=170 Participants	1 participants n=7 Participants	23 participants n=11 Participants
Region of Enrollment France	7 participants n=35 Participants	6 participants n=4328 Participants	0 participants n=8687 Participants	1 participants n=269 Participants	2 participants n=530 Participants	2 participants n=170 Participants	3 participants n=7 Participants	21 participants n=11 Participants
Region of Enrollment Germany	2 participants n=35 Participants	0 participants n=4328 Participants	0 participants n=8687 Participants	0 participants n=269 Participants	0 participants n=530 Participants	2 participants n=170 Participants	0 participants n=7 Participants	4 participants n=11 Participants
Region of Enrollment Spain	3 participants n=35 Participants	0 participants n=4328 Participants	0 participants n=8687 Participants	0 participants n=269 Participants	0 participants n=530 Participants	1 participants n=170 Participants	0 participants n=7 Participants	4 participants n=11 Participants

PRIMARY outcome

Timeframe: 46 months maximum (from baseline up to study end)

Incidences of treatment-emergent serious adverse events using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

Outcome measures

Measure	Cohort 2A (Non-randomized) n=26 Participants Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 Participants Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=13 Participants Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 Participants Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
Treatment-Emergent Serious Adverse Events Assessment	5 Participants	4 Participants	1 Participants	0 Participants	1 Participants	4 Participants	2 Participants

PRIMARY outcome

Timeframe: 46 months maximum (from baseline up to study end)

Incidences of treatment-emergent non-serious adverse events using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

Outcome measures

Measure	Cohort 2A (Non-randomized) n=26 Participants Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 Participants Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=13 Participants Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 Participants Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
Treatment-Emergent Non-Serious Adverse Events	26 Participants	13 Participants	2 Participants	4 Participants	7 Participants	13 Participants	5 Participants

PRIMARY outcome

Timeframe: 46 months maximum (from baseline up to study end)

Incidence of death

Outcome measures

Measure	Cohort 2A (Non-randomized) n=26 Participants Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 Participants Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=13 Participants Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 Participants Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
All Cause Mortalities Assessment	21 Participants	5 Participants	1 Participants	2 Participants	6 Participants	9 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months after treatment start

Progression Free Survival according to iRECIST criteria at 6 months

Outcome measures

Measure	Cohort 2A (Non-randomized) n=26 Participants Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 Participants Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=13 Participants Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 Participants Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
Evaluation of Progression Free Survival	1.9 months Interval 1.8 to 2.3	1.9 months Interval 1.7 to 2.5	1.6 months Interval 1.2 to Insufficient number of participants with events	1.7 months Interval 1.2 to Insufficient number of participants with events	1.9 months Interval 1.2 to 2.7	5.2 months Interval 1.9 to 12.2	19.4 months Interval 3.9 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: 46 months maximum (from baseline up to study end)

Overall survival, defined as the time interval from the date of first study treatment administration to the date of death due to any cause

Outcome measures

Measure	Cohort 2A (Non-randomized) n=26 Participants Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 Participants Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=13 Participants Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 Participants Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
Evaluation of Survival	11.9 months Interval 2.2 to 22.9	NA months Interval 8.6 to Insufficient number of participants with events	NA months Interval 3.0 to Insufficient number of participants with events	NA months Interval 1.6 to Insufficient number of participants with events	24.2 months Interval 1.2 to 33.5	11.4 months Interval 4.6 to Insufficient number of participants with events	NA months Insufficient number of participants with events

SECONDARY outcome

Timeframe: 7 weeks after treatment start

Population: Patient is in C2A-III were treated with nivolumab only (not EO2401)

Expansion of specific T cells comparing samples taken at baseline versus on treatment in an individual patient determining if the patient has a positive response to peptides that compose EO2401, or not. EO2401 immunogenicity is assessed by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) (IVS and ex vivo).

Outcome measures

Measure	Cohort 2A (Non-randomized) n=12 Participants Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=8 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=1 Participants Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=3 Participants Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=8 Participants Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=2 Participants Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
Percentage of Patients With Immunogenicity Against EO2401	12 Participants	8 Participants	0 Participants	0 Participants	3 Participants	5 Participants	2 Participants

Adverse Events

Cohort 2A (Non-randomized)

Serious events: 5 serious events

Other events: 26 other events

Deaths: 21 deaths

Randomized Extension of Cohort 2A (3 Arms): C2A-I

Serious events: 4 serious events

Other events: 13 other events

Deaths: 5 deaths

Randomized Extension of Cohort 2A (3 Arms): C2A-II

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Randomized Extension of Cohort 2A (3 Arms): C2A-III

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Cohort 2B (Non-randomized)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 6 deaths

Cohort 3A (Non-randomized)

Serious events: 4 serious events

Other events: 13 other events

Deaths: 9 deaths

Cohort 3B (Non-randomized)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 2A (Non-randomized) n=26 participants at risk Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 participants at risk Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 participants at risk Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 participants at risk Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 participants at risk Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=13 participants at risk Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 participants at risk Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
Cardiac disorders Cardiac failure	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Cardiac disorders Stress cardiomyopathy	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Abdominal pain upper	3.8% 1/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Constipation	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Enterocolitis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Subileus	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Face oedema	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Hyperthermia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site reaction	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Mucosal inflammation	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Non-cardiac chest pain	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Pyrexia	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Bacteraemia	3.8% 1/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations COVID-19	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Enterocolitis infectious	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Escherichia urinary tract infection	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Gastroenteritis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Influenza	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Foot fracture	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Procedural haemorrhage	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Somnolence	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Renal and urinary disorders Acute kidney injury	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Renal and urinary disorders Renal failure	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Hypertensive crisis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

Other adverse events

Measure	Cohort 2A (Non-randomized) n=26 participants at risk Cohort 2A includes patients (previously treated) with adrenocortical carcinoma. Note, it also includes patients (previously treated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Randomized Extension of Cohort 2A (3 Arms): C2A-I n=13 participants at risk Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 and nivolumab in combination.	Randomized Extension of Cohort 2A (3 Arms): C2A-II n=2 participants at risk Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by EO2401 alone.	Randomized Extension of Cohort 2A (3 Arms): C2A-III n=4 participants at risk Patients with adrenocortical carcinoma belonging to this extension of Cohort 2A (previously treated) have been treated by nivolumab alone.	Cohort 2B (Non-randomized) n=7 participants at risk Cohort 2B includes patients (previously untreated) with adrenocortical carcinoma. Note, it also includes patients (previously untreated) with adrenocortical carcinoma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3A (Non-randomized) n=13 participants at risk Cohort 3A includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously treated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab	Cohort 3B (Non-randomized) n=5 participants at risk Cohort 3B includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma. Note, it also includes patients (previously untreated) with progressive malignant pheochromocytoma/ paraganglioma originally enrolled in Cohort 1 (safety lead-in). EO2401 in combination with nivolumab
Eye disorders Blepharitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Fatigue	23.1% 6/26 • Number of events 8 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	42.9% 3/7 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Swelling	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Blood and lymphatic system disorders Anaemia	23.1% 6/26 • Number of events 6 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	28.6% 2/7 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	38.5% 5/13 • Number of events 5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Blood and lymphatic system disorders Leukocytosis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Blood and lymphatic system disorders Neutropenia	3.8% 1/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Cardiac disorders Myocardial infarction	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Cardiac disorders Palpitations	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Cardiac disorders Tachyarrhythmia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Cardiac disorders Tachycardia	11.5% 3/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Ear and labyrinth disorders Vertigo	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Endocrine disorders Cushing's syndrome	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Endocrine disorders Glucocorticoid deficiency	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Endocrine disorders Hyperthyroidism	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Endocrine disorders Hypothyroidism	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Endocrine disorders Thyroiditis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Eye disorders Lacrimation increased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Abdominal distension	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	28.6% 2/7 • Number of events 5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Abdominal hernia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Abdominal pain	19.2% 5/26 • Number of events 9 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Abdominal pain upper	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Constipation	11.5% 3/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Diarrhoea	34.6% 9/26 • Number of events 9 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	30.8% 4/13 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	42.9% 3/7 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	60.0% 3/5 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Dry mouth	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Dyspepsia	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Dysphagia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Enterocolitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Flatulence	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Lip oedema	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Nausea	19.2% 5/26 • Number of events 6 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	38.5% 5/13 • Number of events 5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Noninfective gingivitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Oesophagitis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Oral mucosal discolouration	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Oral pain	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Paraesthesia oral	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Stomatitis	3.8% 1/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Toothache	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Gastrointestinal disorders Vomiting	23.1% 6/26 • Number of events 10 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Administration site extravasation	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Adverse drug reaction	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Asthenia	15.4% 4/26 • Number of events 5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	69.2% 9/13 • Number of events 11 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	28.6% 2/7 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Chest discomfort	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Chest pain	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Chills	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Feeling cold	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Feeling hot	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders General physical health deterioration	11.5% 3/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Hyperthermia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Immediate post-injection reaction	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Induration	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Inflammation	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Influenza like illness	3.8% 1/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site erosion	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site erythema	7.7% 2/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site haematoma	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site induration	7.7% 2/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 8 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site inflammation	7.7% 2/26 • Number of events 5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site injury	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site oedema	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site pain	19.2% 5/26 • Number of events 6 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	30.8% 4/13 • Number of events 5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	60.0% 3/5 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site plaque	3.8% 1/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site pruritus	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site reaction	34.6% 9/26 • Number of events 26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	46.2% 6/13 • Number of events 7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	100.0% 2/2 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	42.9% 3/7 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	46.2% 6/13 • Number of events 10 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site swelling	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Injection site ulcer	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Localised oedema	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Malaise	7.7% 2/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Mucosal inflammation	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Oedema peripheral	11.5% 3/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	30.8% 4/13 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Pain	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
General disorders Pyrexia	38.5% 10/26 • Number of events 17 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 6 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	42.9% 3/7 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	30.8% 4/13 • Number of events 9 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Hepatobiliary disorders Bile duct stenosis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Hepatobiliary disorders Biliary colic	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Hepatobiliary disorders Hepatic pain	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Abdominal wall infection	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Anal abscess	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Bacterial infection	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Bronchitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations COVID-19	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Candida infection	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Conjunctivitis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Dermo-hypodermitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Diarrhoea infectious	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Enterococcal infection	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Enterocolitis infectious	3.8% 1/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Fungal infection	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Gastroenteritis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Injection site abscess	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Kidney infection	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Laryngopharyngitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Nasopharyngitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Oral bacterial infection	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Oral fungal infection	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Oral herpes	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Periodontitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Pyelonephritis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Sepsis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Sinusitis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Spinal cord infection	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Upper respiratory tract infection	3.8% 1/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Urinary tract infection	11.5% 3/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Infections and infestations Vaginal infection	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Fall	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Head injury	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Infusion related reaction	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Lumbar vertebral fracture	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Radiation injury	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Rib fracture	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Shoulder fracture	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Injury, poisoning and procedural complications Skin wound	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Alanine aminotransferase increased	15.4% 4/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	28.6% 2/7 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Aspartate aminotransferase decreased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Aspartate aminotransferase increased	15.4% 4/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	38.5% 5/13 • Number of events 5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood alkaline phosphatase increased	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood cholesterol increased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood creatinine increased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood lactate dehydrogenase increased	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood phosphorus decreased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood sodium decreased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood thyroid stimulating hormone decreased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Body temperature increased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations C-reactive protein increased	11.5% 3/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Cortisol decreased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Cortisol increased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Electrocardiogram QT prolonged	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Gamma-glutamyltransferase increased	15.4% 4/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	30.8% 4/13 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Gastric pH decreased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Lymphocyte count decreased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Neutrophil count increased	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Neutrophil morphology abnormal	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Platelet count increased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Troponin T increased	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Investigations Weight decreased	11.5% 3/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Decreased appetite	19.2% 5/26 • Number of events 6 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	28.6% 2/7 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hyperlactacidaemia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hypoalbuminaemia	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	28.6% 2/7 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hypokalaemia	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hyponatraemia	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Metabolism and nutrition disorders Vitamin D deficiency	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Arthralgia	11.5% 3/26 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Back pain	26.9% 7/26 • Number of events 8 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Groin pain	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Immune-mediated arthritis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Muscle spasms	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Neck pain	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	23.1% 3/13 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Oligoarthritis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Balance disorder	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Burning sensation	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Dizziness	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Dysarthria	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Dysgeusia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Headache	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	30.8% 4/13 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 3 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Lethargy	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Migraine	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Myoclonus	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Paraesthesia	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Presyncope	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Restless legs syndrome	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Sciatica	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Somnolence	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Nervous system disorders Tremor	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Psychiatric disorders Anxiety	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Psychiatric disorders Confusional state	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Psychiatric disorders Depression	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Psychiatric disorders Hallucination	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Psychiatric disorders Insomnia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Renal and urinary disorders Acute kidney injury	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Renal and urinary disorders Dysuria	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Renal and urinary disorders Proteinuria	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Renal and urinary disorders Urinary retention	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Breast pain	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Endometrial hypertrophy	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Genital haemorrhage	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Intermenstrual bleeding	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Ovarian cyst	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Ovarian disorder	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Reproductive system and breast disorders Testicular pain	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Cough	11.5% 3/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.4% 4/26 • Number of events 4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	50.0% 1/2 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	15.4% 2/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Respiration abnormal	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Erythema	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Papule	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Pruritus	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	40.0% 2/5 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Rash	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Rash macular	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	25.0% 1/4 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Skin mass	7.7% 2/26 • Number of events 2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Skin and subcutaneous tissue disorders Skin ulcer	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Embolism	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Flushing	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Haematoma	3.8% 1/26 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Hypertension	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Hypovolaemic shock	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Malignant hypertension	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Thrombosis	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Varicose vein	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	14.3% 1/7 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders Vein disorder	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	20.0% 1/5 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Vascular disorders White coat hypertension	0.00% 0/26 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	7.7% 1/13 • Number of events 1 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/2 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/4 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/7 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/13 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.	0.00% 0/5 • 46 months maximum (from baseline up to study end) Incidences of deaths and treatment-emergent AEs (Serious and Non-Serious) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.

Additional Information

Jan Fagerberg

Enterome

Phone: +33175772785

Email: info@enterome.com

Results disclosure agreements

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

Restriction type: OTHER