Trial Outcomes & Findings for Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma (NCT NCT03473756)

NCT ID: NCT03473756

Last Updated: 2025-04-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 37 participants
• Primary outcome timeframe: Up to 21 days
• Results posted on: 2025-04-09

Participant Flow

The study was conducted at 30 study centers in 8 countries (4 in Austria, 3 in France, 3 in Germany, 5 in Italy, 4 in Japan, 3 in South Korea, 4 in Spain, and 4 in the US) between 15 May 2018 (first informed consent) and 10 July 2024 (last participant last visit). Only Part A of the study was completed. Part B was not started in line with the protocol. The decision not to conduct Part B was not related to safety concerns but was based on an overall strategic business decision

A total of 54 FGFR mRNA-positive subjects (35.3%) successfully completed the prescreening. Of these, 37 subjects (68.5%) completed the screening and were assigned to treatment and 31.5% prematurely discontinued the screening: 29.6% due to screening failure and 1.9% (1 subject) due to withdrawal by subject.

Participant milestones

Measure	Rogaratinib 800 mg BID + Atezolizumab Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Overall Study STARTED	11	26
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	10	26

Reasons for withdrawal

Measure	Rogaratinib 800 mg BID + Atezolizumab Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Overall Study Withdrawal by Subject	1	4
Overall Study Adverse Event	6	7
Overall Study Lack of Efficacy	3	10
Overall Study Physician Decision	0	2
Overall Study End of study treatment	0	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

Baseline characteristics by cohort

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab	Total n=37 Participants Total of all reporting groups
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized From 65-84 years	9 Participants n=5 Participants	23 Participants n=7 Participants	32 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	23 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	23 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Outcome measures

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Number of Participants With Dose-limiting Toxicities(DLTs)	1 Participants	4 Participants

PRIMARY outcome

Timeframe: up to 90 days after the last study medication intake, an average of 60 days

Outcome measures

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	11 Participants	26 Participants

PRIMARY outcome

Timeframe: up to 90 days after the last study medication intake, an average of 60 days

Outcome measures

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Number of Participants With Drug-related TEAEs	11 Participants	26 Participants

PRIMARY outcome

Timeframe: up to 90 days after the last study medication intake, an average of 60 days

Outcome measures

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Number of Participants With Treatment-emergent Serious Adverse Events(TESAEs)	8 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 5 months

Objective response rate (ORR) was defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom best overall tumor response was not CR or PR, as well as patients without any post-baseline tumor assessment were considered non-responders. For all patients, the best overall tumor response was determined locally by investigators using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Objective Response Rate(ORR) complete response	1 Participants	4 Participants
Objective Response Rate(ORR) partial response	1 Participants	10 Participants
Objective Response Rate(ORR) no response	9 Participants	12 Participants

SECONDARY outcome

Timeframe: At cycle 1 Day 1

Outcome measures

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=25 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Maximal Plasma Concentration (Cmax) of Rogaratinib	13207.846 µg/l Standard Deviation 1.379 • Interval 1.379 to	10372.864 µg/l Standard Deviation 1.404 • Interval 1.404 to

SECONDARY outcome

Timeframe: At cycle 1 Day 1, 0-t(last)

Outcome measures

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 Participants Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=25 Participants Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Area Under the Rogaratinib Concentration Versus Time Curve (AUC)	59187.389 µg*h/l Standard Deviation 1.513	45768.289 µg*h/l Standard Deviation 1.449

Adverse Events

Rogaratinib 800 mg BID + Atezolizumab

Serious events: 8 serious events

Other events: 11 other events

Deaths: 9 deaths

Rogaratinib 600 mg BID + Atezolizumab

Serious events: 14 serious events

Other events: 26 other events

Deaths: 11 deaths

Serious adverse events

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 participants at risk Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 participants at risk Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Cardiac disorders Angina unstable	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Cardiac disorders Atrial fibrillation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Cardiac disorders Cardiac arrest	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Cardiac disorders Supraventricular tachycardia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Constipation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Colitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Intestinal obstruction	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Asthenia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Pyrexia	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders General physical health deterioration	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Hepatobiliary disorders Hepatitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Hepatobiliary disorders Hepatotoxicity	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Urinary tract infection	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Sepsis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Pyelonephritis	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Respiratory tract infection	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Alanine aminotransferase increased	9.1% 1/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Renal function test abnormal	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Syncope	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Renal impairment	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Haematuria	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Circulatory collapse	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Surgical and medical procedures Renal cyst aspiration	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Deep vein thrombosis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days

Other adverse events

Measure	Rogaratinib 800 mg BID + Atezolizumab n=11 participants at risk Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab	Rogaratinib 600 mg BID + Atezolizumab n=26 participants at risk Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab
Surgical and medical procedures Astringent therapy	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Erythromelalgia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Hypertension	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Product Issues Thrombosis in device	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Embolism	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Blood and lymphatic system disorders Anaemia	36.4% 4/11 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Blood and lymphatic system disorders Lymphopenia	9.1% 1/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Blood and lymphatic system disorders Neutropenia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Blood and lymphatic system disorders Neutrophilia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Blood and lymphatic system disorders Leukocytosis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Nail bed inflammation	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Blood and lymphatic system disorders Thrombocytopenia	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Blood and lymphatic system disorders Hypereosinophilic syndrome	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Cardiac disorders Atrial fibrillation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Cardiac disorders Pericardial effusion	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Cardiac disorders Sinus tachycardia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Ear and labyrinth disorders Ear pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Ear and labyrinth disorders Vertigo	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Endocrine disorders Adrenal insufficiency	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Endocrine disorders Hypothyroidism	18.2% 2/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Cataract	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Blepharitis	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Chalazion	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Diplopia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Dry eye	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Eye irritation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Keratitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Keratopathy	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Macular degeneration	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Lacrimation increased	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Maculopathy	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Photopsia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Retinal detachment	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Retinopathy	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Vision blurred	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Visual acuity reduced	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Detachment of retinal pigment epithelium	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Xerophthalmia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Vitreous floaters	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Visual impairment	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Corneal toxicity	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Ocular rosacea	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Detachment of macular retinal pigment epithelium	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Meibomian gland dysfunction	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Retinoschisis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Eye disorders Serous retinopathy	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	26.9% 7/26 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Colitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Ascites	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Aphthous ulcer	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Abdominal pain	27.3% 3/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	26.9% 7/26 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Diarrhoea	63.6% 7/11 • Number of events 20 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	61.5% 16/26 • Number of events 51 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Dry mouth	27.3% 3/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	26.9% 7/26 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Dyspepsia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Eructation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Flatulence	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Haematochezia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Haemorrhoids	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Inguinal hernia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Oral pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Oral lichen planus	9.1% 1/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Nausea	27.3% 3/11 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	38.5% 10/26 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Stomatitis	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Anal erythema	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Tongue erosion	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Asthenia	36.4% 4/11 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	26.9% 7/26 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Toothache	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Vomiting	18.2% 2/11 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	26.9% 7/26 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Rectal discharge	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Gastrointestinal disorders Abdominal hernia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Fatigue	36.4% 4/11 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	42.3% 11/26 • Number of events 26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Chills	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Chest pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Hyperpyrexia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Influenza like illness	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Injection site reaction	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Mucosal inflammation	18.2% 2/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Pain	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Oedema peripheral	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	19.2% 5/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Oedema	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Pyrexia	36.4% 4/11 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	26.9% 7/26 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Early satiety	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders Secretion discharge	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
General disorders General physical health deterioration	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Hepatobiliary disorders Hepatic function abnormal	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Hepatobiliary disorders Hepatitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Hepatobiliary disorders Hyperbilirubinaemia	9.1% 1/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Bronchitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Atypical pneumonia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Hepatobiliary disorders Hypertransaminasaemia	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Conjunctivitis	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Cystitis	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Diverticulitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Fungal skin infection	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Herpes simplex	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Influenza	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Oesophageal candidiasis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Onychomycosis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Oral candidiasis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Paronychia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Escherichia urinary tract infection	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Urinary tract infection	36.4% 4/11 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	34.6% 9/26 • Number of events 29 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Pyelonephritis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Tooth abscess	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Anorectal infection	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Respiratory tract infection	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Herpes dermatitis	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Device related infection	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Oral herpes	9.1% 1/11 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Fall	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Klebsiella urinary tract infection	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations COVID-19	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Candida infection	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Infections and infestations Gastrointestinal viral infection	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Alanine aminotransferase increased	9.1% 1/11 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	30.8% 8/26 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Stoma site ulcer	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Stoma site inflammation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Procedural pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Post procedural fever	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Injury, poisoning and procedural complications Chest injury	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Amylase increased	27.3% 3/11 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	19.2% 5/26 • Number of events 38 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Number of events 22 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	23.1% 6/26 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Blood bilirubin increased	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Blood creatinine increased	27.3% 3/11 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Blood thyroid stimulating hormone decreased	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Blood potassium increased	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Neutrophil count decreased	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Platelet count decreased	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Weight decreased	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Blood phosphorus increased	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Glomerular filtration rate decreased	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Lipase increased	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	23.1% 6/26 • Number of events 39 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Lymphocyte count decreased	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Lymphocyte count increased	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Liver function test increased	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Calcium phosphate product increased	18.2% 2/11 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Renal function test abnormal	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Blood alkaline phosphatase increased	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Transaminases increased	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Investigations Electrocardiogram ST-T segment abnormal	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypertriglyceridaemia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hyperphosphataemia	36.4% 4/11 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	57.7% 15/26 • Number of events 45 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hyperglycaemia	18.2% 2/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypercholesterolaemia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypercalcaemia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hyperlipasaemia	9.1% 1/11 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypercreatininaemia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Decreased appetite	27.3% 3/11 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	30.8% 8/26 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hypophosphataemia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Groin pain	18.2% 2/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Back pain	36.4% 4/11 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	23.1% 6/26 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Arthralgia	27.3% 3/11 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	23.1% 6/26 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Dysgeusia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	23.1% 6/26 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Dizziness	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Amnesia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Headache	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Hyperaesthesia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Hypoaesthesia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Hypotonia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Loss of consciousness	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Taste disorder	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Paraesthesia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Nervous system disorders Memory impairment	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Psychiatric disorders Anxiety	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Haematuria	18.2% 2/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Psychiatric disorders Personality change	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Psychiatric disorders Depression	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Urinary retention	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Renal pain	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Renal failure	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Hydronephrosis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Nocturia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Pollakiuria	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Proteinuria	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Leukocyturia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Reproductive system and breast disorders Pelvic pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Reproductive system and breast disorders Erectile dysfunction	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Dysphonia	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Renal and urinary disorders Renal impairment	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Reproductive system and breast disorders Breast pain	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	19.2% 5/26 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Nasal inflammation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Nail disorder	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	7.7% 2/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Erythema	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Eczema	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Dry skin	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	19.2% 5/26 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Decubitus ulcer	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Palmar erythema	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Nail hypertrophy	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	19.2% 5/26 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Rash	18.2% 2/11 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	19.2% 5/26 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Psoriasis	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Rash macular	9.1% 1/11 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Rash papular	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Rash pruritic	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Xeroderma	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	0.00% 0/26 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	15.4% 4/26 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Deep vein thrombosis	9.1% 1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	3.8% 1/26 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Vascular disorders Hypotension	0.00% 0/11 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days	11.5% 3/26 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days

Additional Information

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Email: clinical-trials-contact@bayer.com

Results disclosure agreements

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

Restriction type: GT60