Trial Outcomes & Findings for MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors (NCT NCT02699515)

NCT ID: NCT02699515

Last Updated: 2024-11-18

Results Overview

A DLT was defined as any grade greater than or equal to (\>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 114 participants
• Primary outcome timeframe: Baseline up to Week 3
• Results posted on: 2024-11-18

Participant Flow

Participant milestones

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Overall Study STARTED	4	3	7	30	31	30	3	6
Overall Study COMPLETED	0	0	0	0	0	1	0	0
Overall Study NOT COMPLETED	4	3	7	30	31	29	3	6

Reasons for withdrawal

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Overall Study Death	3	3	3	23	22	23	3	5
Overall Study Withdrawal by Subject	0	0	3	1	5	3	0	1
Overall Study Other	1	0	1	6	4	3	0	0

Baseline Characteristics

MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer n=30 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Dose Escalation Cohort: M7824 (20 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Gastric Cancer (GC) n=31 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer n=30 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) n=3 Participants Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) n=6 Participants Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Total n=114 Participants Total of all reporting groups
Age, Continuous	51 Years STANDARD_DEVIATION 8.7 • n=93 Participants	57 Years STANDARD_DEVIATION 18.5 • n=4 Participants	63 Years STANDARD_DEVIATION 9.3 • n=27 Participants	54 Years STANDARD_DEVIATION 10.9 • n=483 Participants	62 Years STANDARD_DEVIATION 11.5 • n=36 Participants	60 Years STANDARD_DEVIATION 9.9 • n=10 Participants	58 Years STANDARD_DEVIATION 16.5 • n=115 Participants	56 Years STANDARD_DEVIATION 13.2 • n=40 Participants	61 Years STANDARD_DEVIATION 11.1 • n=8 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	11 Participants n=27 Participants	5 Participants n=483 Participants	5 Participants n=36 Participants	4 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=40 Participants	32 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	0 Participants n=4 Participants	19 Participants n=27 Participants	2 Participants n=483 Participants	26 Participants n=36 Participants	26 Participants n=10 Participants	2 Participants n=115 Participants	5 Participants n=40 Participants	82 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity-Japanese	4 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants	7 Participants n=483 Participants	12 Participants n=36 Participants	17 Participants n=10 Participants	3 Participants n=115 Participants	6 Participants n=40 Participants	64 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity-Korean	0 Participants n=93 Participants	0 Participants n=4 Participants	15 Participants n=27 Participants	0 Participants n=483 Participants	14 Participants n=36 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	32 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity-Taiwanese	0 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	0 Participants n=483 Participants	5 Participants n=36 Participants	10 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	18 Participants n=8 Participants
Race/Ethnicity, Customized Race-Asian	4 Participants n=93 Participants	3 Participants n=4 Participants	30 Participants n=27 Participants	7 Participants n=483 Participants	31 Participants n=36 Participants	30 Participants n=10 Participants	3 Participants n=115 Participants	6 Participants n=40 Participants	114 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 3

Population: DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants received all study treatment administrations in the DLT evaluation period or stopped treatment because of DLTs in the DLT evaluation period.

A DLT was defined as any grade greater than or equal to (>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=6 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Number of Participants With Dose Limiting Toxicity (DLT)	0 Participants	0 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years

Population: Safety Analysis Set (SAF) included all participants who received at least 1 dose of study treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer n=30 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=31 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer n=30 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) n=3 Participants Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) n=6 Participants Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03	4 Participants	3 Participants	6 Participants	28 Participants	30 Participants	30 Participants	2 Participants	6 Participants

PRIMARY outcome

Timeframe: First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years

Population: Safety analysis set included all participants who received at least 1 dose of study treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer n=30 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=31 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer n=30 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) n=3 Participants Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) n=6 Participants Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03	1 Participants	2 Participants	3 Participants	19 Participants	16 Participants	19 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43

Population: Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=9 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824	54.6 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 17.9	211 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 21.7	331 Micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 19.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43

Population: Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

t1/2 was the time measured for the concentration to decrease by one half, determined as 0.693/Lambda z, here Lambda z was the terminal elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=5 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824	132 hours Geometric Coefficient of Variation 12.8	138 hours Geometric Coefficient of Variation 17.4	150 hours Geometric Coefficient of Variation 24.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43

Population: Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated by linear trapezoidal summation.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=8 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=6 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824	7940 hour*microgram per milliliter(hr*mcg/mL) Geometric Coefficient of Variation 16.7	29200 hour*microgram per milliliter(hr*mcg/mL) Geometric Coefficient of Variation 25.3	51300 hour*microgram per milliliter(hr*mcg/mL) Geometric Coefficient of Variation 24.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43

Population: Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=5 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824	9600 hr*mcg/mL Geometric Coefficient of Variation 15.2	34600 hr*mcg/mL Geometric Coefficient of Variation 29.7	61700 hr*mcg/mL Geometric Coefficient of Variation 26.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years

Population: Immunogenicity Analysis Set included participants who received at least 1 dose of study drug and who had at least 1 valid result of ADA at any time point.

The detection of antibodies to M7824 was performed using a validated electrochemiluminescence (ECL) immunoassay with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of M7824 were reported.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=6 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824	1 Participants	0 Participants	3 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Date of randomization up to 2 years

Population: Full analysis set included all participants who received at least 1 dose of study treatment.

BOR was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR was defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=7 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator Complete response	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator Partial response	1 Participants	0 Participants	1 Participants	—	—	—	—	—
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator Stable disease	2 Participants	1 Participants	0 Participants	—	—	—	—	—
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator Progressive disease	1 Participants	2 Participants	4 Participants	—	—	—	—	—
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator Not evaluable	0 Participants	0 Participants	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Date of randomization up to 2 years

Population: Full analysis set included all participants who received at least 1 dose of study treatment.

BOR was assessed by investigator according to RECIST Version 1.1. BOR was defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=31 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator Complete response	1 Participants	2 Participants	0 Participants	—	—	—	—	—
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator Partial response	6 Participants	5 Participants	6 Participants	—	—	—	—	—
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator Stable disease	4 Participants	5 Participants	5 Participants	—	—	—	—	—
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator Progressive disease	17 Participants	16 Participants	17 Participants	—	—	—	—	—
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator Not evaluable	2 Participants	3 Participants	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Full analysis set included all participants who received at least 1 dose of study treatment.

The BOR per Independent Endpoint Review Committee (IRC) adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=31 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer n=3 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=6 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC) Non-CR/Non-PD	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	—	—	—
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC) Progressive disease (PD)	16 Participants	21 Participants	18 Participants	1 Participants	6 Participants	—	—	—
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC) Complete response (CR)	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC) Partial Response (PR)	4 Participants	3 Participants	3 Participants	0 Participants	0 Participants	—	—	—
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC) Stable disease (SD)	6 Participants	2 Participants	3 Participants	1 Participants	0 Participants	—	—	—
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC) Not evaluable (NE)	2 Participants	2 Participants	3 Participants	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Full analysis set included all participants who received at least 1 dose of study treatment.

Duration of response according to RECIST 1.1 as adjudicated by the IRC was defined as the time from first confirmed response until the first documented disease progression that was subsequently confirmed. It was analyzed using Kaplan-Meier method.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=31 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Expansion Part: Duration of Response (DOR)	NA Months Interval 8.3 to 34.5 Due to small number of events, Median from Kaplan-Meier survival curves could not derive.	20.8 Months Interval 2.4 to 29.0	7.0 Months Interval 2.8 to 24.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Full analysis set included all participants who received at least 1 dose of study treatment.

The disease control rate was defined as the percentage of participants with BOR. The BOR per IRC adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=31 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=30 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer n=3 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=6 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Expansion Part: Disease Control Rate	40.0 Percentage of Participants Interval 22.7 to 59.4	22.6 Percentage of Participants Interval 11.9 to 44.6	20 Percentage of Participants Interval 14.7 to 49.4	1 Percentage of Participants Interval 0.8 to 90.6	0 Percentage of Participants Interval 0.0 to 45.9	—	—	—

SECONDARY outcome

Timeframe: Date of randomization until death or progressive disease assessed up to 2 years

Population: Full analysis set included all participants who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as RECIST v1.1 as adjudicated by IRC. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=25 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=25 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=26 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer n=3 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=6 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Expansion Part: Progression Free Survival (PFS) Time	2.5 Months Interval 0.0 to 38.6	1.3 Months Interval 0.4 to 31.6	1.4 Months Interval 0.0 to 30.3	2.1 Months Interval 1.3 to 2.8	1.2 Months Interval 0.8 to 2.7	—	—	—

SECONDARY outcome

Timeframe: Date of randomization until death assessed up to 2 years

Population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

OS was defined as the time from randomization to death due to any cause.

Outcome measures

Measure	Dose Escalation Cohort: M7824 (3 mg/kg) n=19 Participants Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=21 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=6 Participants Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Biliary Tract Cancer n=3 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=6 Participants Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Expansion Part: Overall Survival (OS) Time	12.7 Months Interval 1.9 to 38.7	10.1 Months Interval 0.5 to 38.3	11.9 Months Interval 0.1 to 38.0	4.4 Months Interval 4.3 to 6.9	4.0 Months Interval 2.1 to Due to small number of events, Upper limit from Kaplan-Meier survival curves could not derive.	—	—	—

Adverse Events

Expansion Cohort: Biliary Tract Cancer

Serious events: 18 serious events

Other events: 28 other events

Deaths: 23 deaths

Expansion Cohort: Gastric Cancer (GC)

Serious events: 18 serious events

Other events: 30 other events

Deaths: 22 deaths

Expansion Cohort: Esophageal Squamous Cell Cancer

Serious events: 14 serious events

Other events: 30 other events

Deaths: 24 deaths

Dose Escalation Cohort: M7824 (3 mg/kg)

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Dose Escalation Cohort: M7824 (10 mg/kg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Escalation Cohort: M7824 (20 mg/kg)

Serious events: 5 serious events

Other events: 6 other events

Deaths: 3 deaths

Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg)

Serious events: 2 serious events

Other events: 1 other events

Deaths: 3 deaths

Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

Serious adverse events

Measure	Expansion Cohort: Biliary Tract Cancer n=30 participants at risk Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=31 participants at risk Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer n=30 participants at risk Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 participants at risk Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 participants at risk Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=7 participants at risk Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) n=3 participants at risk Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) n=6 participants at risk Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Gastrointestinal disorders Vomiting	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Disease progression	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	12.9% 4/31 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Non-cardiac chest pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Ear and labyrinth disorders Hypoacusis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Endocrine disorders Adrenal insufficiency	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Endocrine disorders Hypopituitarism	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Vitreous haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Abdominal pain	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Ascites	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Diarrhoea	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Dysphagia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Haemorrhoids	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Ileus	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Melaena	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Nausea	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Obstruction gastric	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Performance status decreased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Pyrexia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Sudden death	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Cholangitis	13.3% 4/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Jaundice	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Jaundice cholestatic	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Bacterial infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Biliary tract infection	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Device related infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Diarrhoea infectious	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Herpes zoster	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Kaposi's varicelliform eruption	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Liver abscess	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Pneumonia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Septic shock	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Fall	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Incisional hernia	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Alanine aminotransferase increased	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Aspartate aminotransferase increased	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood alkaline phosphatase increased	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood creatine phosphokinase increased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Gamma-glutamyltransferase increased	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Decreased appetite	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	75.0% 3/4 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Diplegia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Product Issues Device malfunction	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Rash	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Rash pruritic	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.

Other adverse events

Measure	Expansion Cohort: Biliary Tract Cancer n=30 participants at risk Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Gastric Cancer (GC) n=31 participants at risk Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Esophageal Squamous Cell Cancer n=30 participants at risk Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Dose Escalation Cohort: M7824 (3 mg/kg) n=4 participants at risk Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.	Dose Escalation Cohort: M7824 (10 mg/kg) n=3 participants at risk Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.	Dose Escalation Cohort: M7824 (20 mg/kg) n=7 participants at risk Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.	Expansion Cohort: Hepatocellular Carcinoma (3 mg/kg) n=3 participants at risk Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.	Expansion Cohort: Hepatocellular Carcinoma (10 mg/kg) n=6 participants at risk Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
General disorders Pyrexia	43.3% 13/30 • Number of events 22 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	22.6% 7/31 • Number of events 10 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 5/30 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	42.9% 3/7 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Biliary dilatation	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Blood and lymphatic system disorders Anaemia	33.3% 10/30 • Number of events 15 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	35.5% 11/31 • Number of events 16 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	23.3% 7/30 • Number of events 11 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	75.0% 3/4 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	28.6% 2/7 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Cardiac disorders Atrioventricular block first degree	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Cardiac disorders Palpitations	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Cardiac disorders Tachycardia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Congenital, familial and genetic disorders Epidermal naevus	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Ear and labyrinth disorders Meniere's disease	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Ear and labyrinth disorders Tinnitus	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Ear and labyrinth disorders Vertigo	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Endocrine disorders Adrenal insufficiency	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Endocrine disorders Hyperthyroidism	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Endocrine disorders Hypopituitarism	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Endocrine disorders Hypothyroidism	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	20.0% 6/30 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Endocrine disorders Thyroiditis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Blepharitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Cataract	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Conjunctival haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Diabetic retinopathy	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Dry eye	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Eye pruritus	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Eyelid ptosis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Glaucoma	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Keratitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Photophobia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Retinal haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Retinal vasculitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Vision blurred	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Vitreous floaters	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Eye disorders Vitreous haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Abdominal discomfort	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Abdominal distension	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Abdominal pain	20.0% 6/30 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	19.4% 6/31 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Ascites	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Constipation	13.3% 4/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	22.6% 7/31 • Number of events 7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 5/30 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Dental caries	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Diarrhoea	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 2/6 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Dry mouth	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Duodenal ulcer	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Dyspepsia	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Dysphagia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Enterocolitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gastric ulcer	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gastric varices	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gastritis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gingival bleeding	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Gingival erosion	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Glossitis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Haemorrhoids	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Ileus	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Large intestine polyp	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Lip dry	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Loose tooth	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Malignant gastrointestinal obstruction	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Mouth ulceration	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Nausea	13.3% 4/30 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.1% 5/31 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	13.3% 4/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Oesophageal mucosal hyperplasia	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Periodontal disease	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Proctitis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Stomatitis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Stress ulcer	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Toothache	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Varices oesophageal	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Gastrointestinal disorders Vomiting	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Asthenia	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Catheter site pain	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Chest discomfort	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Chest pain	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Chills	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Fatigue	16.7% 5/30 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	19.4% 6/31 • Number of events 7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Granuloma	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Impaired healing	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Malaise	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	13.3% 4/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Medical device site pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Nodule	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Non-cardiac chest pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Oedema	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
General disorders Oedema peripheral	13.3% 4/30 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 2/6 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Cholangitis	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Hepatic failure	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Hepatitis cholestatic	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Hepatitis chronic active	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Immune system disorders Contrast media allergy	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Immune system disorders Drug hypersensitivity	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Acarodermatitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Bacteraemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Bacterial infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Carbuncle	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Cystitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Hordeolum	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Influenza	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Liver abscess	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Medical device site infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Nasopharyngitis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 8 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Otitis media chronic	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Paronychia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Periodontitis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Peritonitis bacterial	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Pharyngitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Pitted keratolysis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Pneumonia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Pyelitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Rash pustular	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Sepsis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Sinusitis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Skin infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Upper respiratory tract infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	12.9% 4/31 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Urinary tract infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Infections and infestations Wound infection	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Contusion	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Fall	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Femur fracture	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Infusion related reaction	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Pelvic fracture	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Procedural pain	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Scapula fracture	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Spinal compression fracture	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Injury, poisoning and procedural complications Suture related complication	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Alanine aminotransferase increased	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Amylase increased	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Aspartate aminotransferase increased	6.7% 2/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Bilirubin conjugated increased	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood alkaline phosphatase	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood alkaline phosphatase increased	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood bilirubin increased	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood creatine phosphokinase increased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood creatinine increased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	50.0% 2/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Blood lactate dehydrogenase increased	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Electrocardiogram QT prolonged	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Gamma-glutamyltransferase increased	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Glycosylated haemoglobin increased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Haemoglobin decreased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Lipase increased	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Lymphocyte count decreased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Platelet count decreased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations Weight decreased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Investigations White blood cell count increased	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Decreased appetite	23.3% 7/30 • Number of events 7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	22.6% 7/31 • Number of events 8 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	13.3% 4/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	100.0% 4/4 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hyperglycaemia	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 5/30 • Number of events 7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	19.4% 6/31 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypokalaemia	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypophagia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	42.9% 3/7 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Type 2 diabetes mellitus	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Metabolism and nutrition disorders Zinc deficiency	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Back pain	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	9.7% 3/31 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Muscle swelling	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Neck pain	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Pathological fracture	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Periarthritis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	13.3% 4/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	28.6% 2/7 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	10.0% 3/30 • Number of events 8 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 9 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	3.3% 1/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Diplegia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Dizziness	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Dysgeusia	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Femoral nerve palsy	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Headache	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	12.9% 4/31 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Hydrocephalus	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Hypoaesthesia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Neuralgia	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Polyneuropathy	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Nervous system disorders Somnolence	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Product Issues Device occlusion	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Psychiatric disorders Anxiety disorder	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Psychiatric disorders Delirium	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Psychiatric disorders Insomnia	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Psychiatric disorders Major depression	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Renal and urinary disorders Acute kidney injury	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Renal and urinary disorders Dysuria	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Renal and urinary disorders Haematuria	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Renal and urinary disorders Pollakiuria	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Renal and urinary disorders Renal impairment	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Renal and urinary disorders Urinary retention	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Reproductive system and breast disorders Breast cyst	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Acquired tracheo-oesophageal fistula	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.5% 2/31 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Productive cough	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Acanthosis nigricans	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Acne	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Dermatitis acneiform	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	14.3% 1/7 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Drug eruption	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Dry skin	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Eczema	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Eczema asteatotic	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Keratosis pilaris	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Lichenoid keratosis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Milia	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Neurodermatitis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Papule	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.2% 1/31 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Pruritus	6.7% 2/30 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	22.6% 7/31 • Number of events 7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	10.0% 3/30 • Number of events 4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Psoriasis	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Rash	13.3% 4/30 • Number of events 5 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.1% 5/31 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 5/30 • Number of events 6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	13.3% 4/30 • Number of events 8 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	22.6% 7/31 • Number of events 9 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	20.0% 6/30 • Number of events 7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	33.3% 1/3 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Rash pruritic	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Skin depigmentation	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Skin fibrosis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Skin mass	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Solar dermatitis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Urticaria	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	25.0% 1/4 • Number of events 3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Skin and subcutaneous tissue disorders Urticaria chronic	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Vascular disorders Deep vein thrombosis	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Vascular disorders Hypertension	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/30 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	16.7% 1/6 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
Vascular disorders Hypotension	6.7% 2/30 • Number of events 2 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/31 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	3.3% 1/30 • Number of events 1 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/4 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/7 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/3 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.	0.00% 0/6 • First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: service@emdgroup.com

Results disclosure agreements

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