Trial Outcomes & Findings for Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies (NCT NCT02906670)

NCT ID: NCT02906670

Last Updated: 2020-08-28

Results Overview

Assess the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of Sym013 administration.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

32 participants

Primary outcome timeframe

24 months

Results posted on

2020-08-28

Participant Flow

Patients were only recruited for Part 1; a recommended Phase 2 dose (RP2D) could not be established and the part 2 cohorts A, B, C and were not initiated.

Participant milestones

Participant milestones
Measure	1 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	2 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	4 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	6 mg/kg Q1W + Prophylaxis Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	9 mg/kg Q1W + Prophylaxis Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	6 mg/kg Q2W Phase 1a: Patients are administered 6 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	9 mg/kg Q2W Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	9 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	12 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered 12 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	15 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered 15 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Cohort 1, QW STARTED	1	0	0	0	0	0	0	0	0	0
Cohort 1, QW COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 1, QW NOT COMPLETED	1	0	0	0	0	0	0	0	0	0
Cohort 2, QW STARTED	0	1	0	0	0	0	0	0	0	0
Cohort 2, QW COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 2, QW NOT COMPLETED	0	1	0	0	0	0	0	0	0	0
Cohort 3, QW STARTED	0	0	4	0	0	0	0	0	0	0
Cohort 3, QW COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 3, QW NOT COMPLETED	0	0	4	0	0	0	0	0	0	0
Cohort 4, Q2W STARTED	0	0	0	0	0	3	0	0	0	0
Cohort 4, Q2W COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 4, Q2W NOT COMPLETED	0	0	0	0	0	3	0	0	0	0
Cohort 5, Q2W STARTED	0	0	0	0	0	0	7	0	0	0
Cohort 5, Q2W COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 5, Q2W NOT COMPLETED	0	0	0	0	0	0	7	0	0	0
Cohort 5P, Q2W STARTED	0	0	0	0	0	0	0	3	0	0
Cohort 5P, Q2W COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 5P, Q2W NOT COMPLETED	0	0	0	0	0	0	0	3	0	0
Cohort 6P, Q2W STARTED	0	0	0	0	0	0	0	0	4	0
Cohort 6P, Q2W COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 6P, Q2W NOT COMPLETED	0	0	0	0	0	0	0	0	4	0
Cohort 4P, QW STARTED	0	0	0	3	0	0	0	0	0	0
Cohort 4P, QW COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 4P, QW NOT COMPLETED	0	0	0	3	0	0	0	0	0	0
Cohort 7P, Q2W STARTED	0	0	0	0	0	0	0	0	0	3
Cohort 7P, Q2W COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 7P, Q2W NOT COMPLETED	0	0	0	0	0	0	0	0	0	3
Cohort 5P, QW STARTED	0	0	0	0	3	0	0	0	0	0
Cohort 5P, QW COMPLETED	0	0	0	0	0	0	0	0	0	0
Cohort 5P, QW NOT COMPLETED	0	0	0	0	3	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	1 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	2 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	4 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	6 mg/kg Q1W + Prophylaxis Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	9 mg/kg Q1W + Prophylaxis Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	6 mg/kg Q2W Phase 1a: Patients are administered 6 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	9 mg/kg Q2W Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw.	9 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered 9 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	12 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered 12 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	15 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered 15 mg/kg of Sym013 every second week for 4 weeks until unacceptable toxicity, progressive disease, termination of the trial or patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Cohort 1, QW Radiological Progression	1	0	0	0	0	0	0	0	0	0
Cohort 2, QW Radiological Progression	0	1	0	0	0	0	0	0	0	0
Cohort 3, QW Radiological Progression	0	0	2	0	0	0	0	0	0	0
Cohort 3, QW Lack of Clinical Benefit	0	0	2	0	0	0	0	0	0	0
Cohort 4, Q2W Radiological Progression	0	0	0	0	0	1	0	0	0	0
Cohort 4, Q2W Clinical Progression	0	0	0	0	0	2	0	0	0	0
Cohort 5, Q2W Radiological Progression	0	0	0	0	0	0	4	0	0	0
Cohort 5, Q2W Clinical Progression	0	0	0	0	0	0	1	0	0	0
Cohort 5, Q2W Adverse Event	0	0	0	0	0	0	1	0	0	0
Cohort 5, Q2W Lack of Clinical Benefit	0	0	0	0	0	0	1	0	0	0
Cohort 5P, Q2W Radiological Progression	0	0	0	0	0	0	0	2	0	0
Cohort 5P, Q2W Adverse Event	0	0	0	0	0	0	0	1	0	0
Cohort 6P, Q2W Radiological Progression	0	0	0	0	0	0	0	0	1	0
Cohort 6P, Q2W Clinical Progression	0	0	0	0	0	0	0	0	3	0
Cohort 4P, QW Radiological Progression	0	0	0	3	0	0	0	0	0	0
Cohort 7P, Q2W Adverse Event	0	0	0	0	0	0	0	0	0	1
Cohort 7P, Q2W Physician Decision	0	0	0	0	0	0	0	0	0	1
Cohort 7P, Q2W More than 3 Dose-reduction of Pan-Her	0	0	0	0	0	0	0	0	0	1
Cohort 5P, QW Radiological Progression	0	0	0	0	3	0	0	0	0	0

Baseline Characteristics

Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 mg/kg Q1W n=1 Participants Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	2 mg/kg Q1W n=1 Participants Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	4 mg/kg Q1W n=4 Participants Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	6 mg/kg Q1W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	9 mg/kg Q1W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	6 mg/kg Q2W n=3 Participants Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W n=7 Participants Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	12 mg/kg Q2W + Prophylaxis n=4 Participants Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	15 mg/kg Q2W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	2 Participants n=7 Participants	1 Participants n=31 Participants	2 Participants n=30 Participants	6 Participants n=3 Participants	1 Participants n=6 Participants	1 Participants n=114 Participants	2 Participants	20 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants	1 Participants n=30 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants	3 Participants n=114 Participants	1 Participants	12 Participants n=19 Participants
Age, Continuous	54.0 Years n=99 Participants	57.0 Years n=107 Participants	59.3 Years STANDARD_DEVIATION 9.74 • n=206 Participants	58.0 Years STANDARD_DEVIATION 6.08 • n=7 Participants	63.3 Years STANDARD_DEVIATION 11.24 • n=31 Participants	56.0 Years STANDARD_DEVIATION 12.12 • n=30 Participants	51.6 Years STANDARD_DEVIATION 11.59 • n=3 Participants	67.3 Years STANDARD_DEVIATION 10.02 • n=6 Participants	63.8 Years STANDARD_DEVIATION 13.77 • n=114 Participants	59.7 Years STANDARD_DEVIATION 8.02	58.7 Years STANDARD_DEVIATION 10.48 • n=19 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants	1 Participants n=30 Participants	3 Participants n=3 Participants	3 Participants n=6 Participants	1 Participants n=114 Participants	1 Participants	12 Participants n=19 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	1 Participants n=31 Participants	2 Participants n=30 Participants	4 Participants n=3 Participants	0 Participants n=6 Participants	3 Participants n=114 Participants	2 Participants	20 Participants n=19 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=114 Participants	1 Participants	6 Participants n=19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	1 Participants n=7 Participants	3 Participants n=31 Participants	3 Participants n=30 Participants	6 Participants n=3 Participants	2 Participants n=6 Participants	4 Participants n=114 Participants	2 Participants	26 Participants n=19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	1 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	1 Participants n=30 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	3 Participants n=19 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	2 Participants n=31 Participants	2 Participants n=30 Participants	6 Participants n=3 Participants	2 Participants n=6 Participants	4 Participants n=114 Participants	3 Participants	27 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	1 Participants n=19 Participants
Region of Enrollment United States	1 participants n=99 Participants	1 participants n=107 Participants	4 participants n=206 Participants	3 participants n=7 Participants	3 participants n=31 Participants	3 participants n=30 Participants	7 participants n=3 Participants	3 participants n=6 Participants	4 participants n=114 Participants	3 participants	32 participants n=19 Participants
Body Mass Index (BMI)	36.2 kg/m^2 n=99 Participants	26.30 kg/m^2 n=107 Participants	27.45 kg/m^2 STANDARD_DEVIATION 7.543 • n=206 Participants	26.00 kg/m^2 STANDARD_DEVIATION 2.893 • n=7 Participants	26.93 kg/m^2 STANDARD_DEVIATION 2.409 • n=31 Participants	27.13 kg/m^2 STANDARD_DEVIATION 2.122 • n=30 Participants	26.84 kg/m^2 STANDARD_DEVIATION 5.828 • n=3 Participants	24.03 kg/m^2 STANDARD_DEVIATION 6.584 • n=6 Participants	21.98 kg/m^2 STANDARD_DEVIATION 1.981 • n=114 Participants	31.83 kg/m^2 STANDARD_DEVIATION 9.178	26.75 kg/m^2 STANDARD_DEVIATION 5.575 • n=19 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Pts 84001-007 (9mg/kg Q2W) and 84002-01 (12 mg/kg +P Q2W) did not complete C1 and hence is not considered eligible for DLT assessments.

Assess the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of Sym013 administration.

Outcome measures

Outcome measures
Measure	1 mg/kg Q1W n=1 Participants Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	2 mg/kg Q1W n=1 Participants Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	4 mg/kg Q1W n=4 Participants Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	6 mg/kg Q1W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	9 mg/kg Q1W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	6 mg/kg Q2W n=3 Participants Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W n=6 Participants Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	12 mg/kg Q2W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	15 mg/kg Q2W + Prophylaxis n=3 Participants Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	Phase 2a Dose-Expansion Cohort A Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets. Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.	Phase 2a Dose-Expansion Cohort B Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets. Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.	Phase 2a Dose-Expansion Cohort C Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets. Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.	Phase 2a Dose-Expansion Cohort D Part 2 is a Phase 2a dose-expansion with Sym013 at the RP2D and regimen. One (1) of 4 tumor types to be evaluated in this arm of the trial will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets. Sym013: Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1 mg/kg Q1W n=1 participants at risk Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	2 mg/kg Q1W n=1 participants at risk Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	4 mg/kg Q1W n=4 participants at risk Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	6 mg/kg Q1W + Prophylaxis n=3 participants at risk Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	9 mg/kg Q1W + Prophylaxis n=3 participants at risk Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	6 mg/kg Q2W n=3 participants at risk Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W n=7 participants at risk Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W + Prophylaxis n=3 participants at risk Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	12 mg/kg Q2W + Prophylaxis n=4 participants at risk Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	15 mg/kg Q2W + Prophylaxis n=3 participants at risk；n=7 participants at risk Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	28.6% 2/7 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Oesophagitis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Cardiac disorders Pericardial effusion	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Sepsis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Electrocardiogram QT prolonged	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.

Other adverse events

Other adverse events
Measure	1 mg/kg Q1W n=1 participants at risk Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	2 mg/kg Q1W n=1 participants at risk Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	4 mg/kg Q1W n=4 participants at risk Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	6 mg/kg Q1W + Prophylaxis n=3 participants at risk Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	9 mg/kg Q1W + Prophylaxis n=3 participants at risk Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	6 mg/kg Q2W n=3 participants at risk Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W n=7 participants at risk Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	9 mg/kg Q2W + Prophylaxis n=3 participants at risk Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	12 mg/kg Q2W + Prophylaxis n=4 participants at risk Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	15 mg/kg Q2W + Prophylaxis n=3 participants at risk；n=7 participants at risk Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.
Gastrointestinal disorders Oral pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 4/4 • Number of events 10 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 9 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	85.7% 6/7 • Number of events 9 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	75.0% 3/4 • Number of events 5 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	75.0% 3/4 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Nausea	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 3/3 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Vomiting	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Constipation	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	28.6% 2/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Anal inflammation	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Cheilitis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Flatulence	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Lip pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Glossitis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Lip oedema	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Oesophagitis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Dysphagai	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	50.0% 2/4 • Number of events 5 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 3/3 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 3/3 • Number of events 7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 6 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	71.4% 5/7 • Number of events 8 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Pruritus	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	50.0% 2/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Dry skin	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Skin and subcutaneous tissue disorders Skin oedema	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	50.0% 2/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	42.9% 3/7 • Number of events 5 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	75.0% 3/4 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Injury, poisoning and procedural complications Laceration	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Injury, poisoning and procedural complications Eyelid injury	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Injury, poisoning and procedural complications Incision site erythema	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Fatigue	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	75.0% 3/4 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Oedema peripheral	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Disease progression	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Early satiety	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Gait disturbance	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Localised oedema	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Malaise	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Pyrexia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
General disorders Influenza like illness	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Weight decreased	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	28.6% 2/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Blood bilirubin increased	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Electrocardiogram QT prolonged	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Lymphocyte count decreased	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Blood creatinine increased	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Investigations Lipase increased	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	42.9% 3/7 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	66.7% 2/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	28.6% 2/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Oral candidiasis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Paronychia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Eye infection	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Hordeolum	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Sepsis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Sinusitis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Urinary tract infection	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Tinea cruris	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Infections and infestations Upper respiratory tract infection	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Vascular disorders Flushing	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Vascular disorders Hypotension	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Vascular disorders Haematoma	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Nervous system disorders Dysgeusia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Nervous system disorders Dysaesthesia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Nervous system disorders Headache	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Nervous system disorders Dizziness	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Nervous system disorders Paraesthesia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Psychiatric disorders Depression	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Psychiatric disorders Insomnia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Psychiatric disorders Confusional state	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Cardiac disorders Cardiac tamponade	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Cardiac disorders Palpitations	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Cardiac disorders Pericardial effusion	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	25.0% 1/4 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Eye disorders Dry eye	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Eye disorders Episcleritis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Eye disorders Periorbital	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Eye disorders Vision blurred	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Eye disorders Diplopia	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	100.0% 1/1 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 2 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	33.3% 1/3 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/7 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.
Hepatobiliary disorders Hepatobiliary disorders	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	14.3% 1/7 • Number of events 1 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/4 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.	0.00% 0/3 • All AEs will be recorded from signing of informed consent for participation in the trial. The recording period ends at the time of the 1 month follow-up Visit.

Additional Information

Medical Director

Symphogen AS

Phone: 004545265050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60