Trial Outcomes & Findings for Sym004 in Patients With Advanced Solid Tumors (NCT NCT01117428)

Last Updated: 2018-10-15

Results Overview

The AEs were used as a primary endpoint. AEs were summarized using descriptive statistics and presented overall by system organ class and preferred term. The frequencies of AEs were presented including number and percentages of participants with events and the total number of events.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

111 participants

Primary outcome timeframe

Visit 2 until first follow-up visit (up to 66 weeks)

Results posted on

2018-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Part A: Dose Escalation Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-epidermal growth factor receptor (anti-EGFR) antibody refractory metastatic colorectal cancer (mCRC). Sym004: 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Overall Study STARTED	20	29	13	12	17	20
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	20	29	13	12	17	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Dose Escalation Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-epidermal growth factor receptor (anti-EGFR) antibody refractory metastatic colorectal cancer (mCRC). Sym004: 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Overall Study Lack of Efficacy	1	0	0	0	0	0
Overall Study Adverse Event	4	0	0	0	1	2
Overall Study Death	0	1	2	0	0	1
Overall Study Physician Decision	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	1	0	0	0
Overall Study Progressive disease	15	27	10	12	16	17

Baseline Characteristics

Sym004 in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Dose Escalation n=20 Participants Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort n=29 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort n=13 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort n=12 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort n=17 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort n=20 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	16 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants	11 Participants n=10 Participants	57 Participants n=115 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	9 Participants n=10 Participants	54 Participants n=115 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	49 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=10 Participants	62 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	28 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	16 Participants n=21 Participants	20 Participants n=10 Participants	104 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	5 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	3 participants n=10 Participants	9 participants n=115 Participants
Region of Enrollment United States	11 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	11 participants n=115 Participants
Region of Enrollment Spain	9 participants n=5 Participants	24 participants n=7 Participants	12 participants n=5 Participants	12 participants n=4 Participants	17 participants n=21 Participants	17 participants n=10 Participants	91 participants n=115 Participants
Disease duration	4.2 years STANDARD_DEVIATION 2.7 • n=5 Participants	3.6 years STANDARD_DEVIATION 1.6 • n=7 Participants	4.1 years STANDARD_DEVIATION 2.7 • n=5 Participants	2.8 years STANDARD_DEVIATION 1.0 • n=4 Participants	4.0 years STANDARD_DEVIATION 2.9 • n=21 Participants	3.8 years STANDARD_DEVIATION 2.3 • n=10 Participants	NA years STANDARD_DEVIATION NA • n=115 Participants

PRIMARY outcome

Timeframe: Visit 2 until first follow-up visit (up to 66 weeks)

Outcome measures

Outcome measures
Measure	Part A: Dose Escalation n=20 Participants Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort n=29 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort n=13 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort n=12 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort n=17 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort n=20 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Number of Participants With Adverse Events (AEs)	20 Participants	29 Participants	13 Participants	12 Participants	17 Participants	20 Participants

SECONDARY outcome

Timeframe: Up to 62 weeks

Population: Data for Part A were presented only for the FAS. For Parts B to F, analyses and summaries were performed both for the FAS and for the per protocol population. The FAS was considered the primary analysis population.

Best Overall Response (OR) on the Full Analysis Set (FAS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, based on central evaluation with confirmatory CT scan or MRI \[Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR): CR + PR\]. Baseline was defined as Visit 2 (pre-infusion). The outcome measure was measured from screening until PD.

Outcome measures

Outcome measures
Measure	Part A: Dose Escalation n=20 Participants Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort n=29 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort n=13 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort n=12 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort n=17 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort n=20 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Antitumor Activity Stable Disease	45 percentage of participants Interval 23.1 to 68.5	58.6 percentage of participants Interval 38.9 to 76.5	46.2 percentage of participants Interval 19.2 to 74.9	16.7 percentage of participants Interval 2.1 to 48.4	70.6 percentage of participants Interval 44.0 to 89.7	65 percentage of participants Interval 40.8 to 84.6
Antitumor Activity Progressive Disease	40 percentage of participants Interval 19.1 to 63.9	24.1 percentage of participants Interval 10.3 to 43.5	30.8 percentage of participants Interval 9.1 to 61.4	75 percentage of participants Interval 42.8 to 94.5	17.6 percentage of participants Interval 3.8 to 43.4	30 percentage of participants Interval 11.9 to 54.3
Antitumor Activity Partial Response	0 percentage of participants Interval 0.0 to 0.0	6.9 percentage of participants Interval 0.8 to 22.8	7.7 percentage of participants Interval 0.2 to 36.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0
Antitumor Activity Missing	15 percentage of participants Interval 3.2 to 37.9	6.9 percentage of participants Interval 0.8 to 22.8	7.7 percentage of participants Interval 0.2 to 36.0	0 percentage of participants Interval 0.0 to 0.0	11.8 percentage of participants Interval 1.5 to 36.4	5 percentage of participants Interval 0.1 to 24.9
Antitumor Activity Not Evaluable	0 percentage of participants Interval 0.0 to 0.0	3.4 percentage of participants Interval 0.1 to 17.8	7.7 percentage of participants Interval 0.2 to 36.0	8.3 percentage of participants Interval 0.2 to 38.5	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 62 weeks

Median Progression Free Survival (PFS) was defined as the time interval without PD from start of first infusion until death or documented PD (i.e. at least a 20% increase in the sum of diameters of target lesions) according to RECIST v1.1. Patients who died without confirmed PD were considered as progressed. Patients who died or showed PD more than 21 days after last treatment were censored (i.e. were considered alive without progression on Day 21 after last treatment). Patients without events were censored at date of last scan or 22 days after last treatment, whichever occurred first. Median Overall Survival (OS) was defined as the time from start of first infusion until date of death from any cause. Patients alive at the time of the analysis or prematurely withdrawn from the trial (e.g. lost to follow-up or consent withdrawn) were censored for the OS analysis. In any case of censoring, the date of censoring was the last time point documenting survival status.

Outcome measures

Outcome measures
Measure	Part A: Dose Escalation n=20 Participants Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort n=29 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort n=13 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort n=12 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort n=17 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort n=20 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Antitumor Activity Endpoints - Time-to-event Endpoints Overall Survival	7.9 Months Interval 2.9 to 10.3	6.9 Months Interval 3.8 to 10.4	6.2 Months Interval 1.6 to 10.5	2.9 Months Interval 1.1 to 13.5	6.3 Months Interval 4.0 to 10.3	9.6 Months Interval 5.5 to 12.6
Antitumor Activity Endpoints - Time-to-event Endpoints Progression Free Survival	3 Months Interval 1.4 to 5.1	3.6 Months Interval 1.4 to 5.1	3.3 Months Interval 1.2 to 5.2	1.4 Months Interval 1.2 to 1.4	3.3 Months Interval 1.4 to 5.1	3.1 Months Interval 1.4 to 3.6

SECONDARY outcome

Timeframe: See Time Frame in the Outcome Measure Description

Population: For Part A, data could not be reported as the endpoint was not calculated and no pharmacokinetics (PK) analysis set was defined. For Parts B to F, a PK analysis set was used.

For Part A, the endpoint was not calculated. For Parts B, C and F, the endpoint was calculated for each patient following the first and fourth Sym004 infusions. For Parts D and E, the endpoint was calculated for each patient following the first and third Sym004 infusions. T½ was estimated using non-compartmental methods and actual time points. Outcome Measure Time Frame: Parts B, C and F (Weekly dosing): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) until 1 week post-infusion (168-hours) and at Visit 5 (4th dose from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 1 week post-infusion (168-hours). Parts D, E (Dosing every second week): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) to end of 3rd dose (from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 2 weeks post-infusion (336 hours).

Outcome measures

Outcome measures
Measure	Part A: Dose Escalation Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004: 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort n=17 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort n=6 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort n=12 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort n=16 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort n=20 Participants Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004: 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Terminal Half-Life (T½) 1st Dose	—	74.8 Hours Geometric Coefficient of Variation 20.9	61.8 Hours Geometric Coefficient of Variation 20	65.6 Hours Geometric Coefficient of Variation 33.6	108 Hours Geometric Coefficient of Variation 18.9	66.6 Hours Geometric Coefficient of Variation 21.2
Terminal Half-Life (T½) 3rd Dose	—	0 Hours Geometric Coefficient of Variation 0	0 Hours Geometric Coefficient of Variation 0	88.7 Hours Geometric Coefficient of Variation 41.8	120.7 Hours Geometric Coefficient of Variation 25.5	0 Hours Geometric Coefficient of Variation 0
Terminal Half-Life (T½) 4th Dose	—	123.6 Hours Geometric Coefficient of Variation 38.9	120.7 Hours Geometric Coefficient of Variation 23.5	0 Hours Geometric Coefficient of Variation 0	0 Hours Geometric Coefficient of Variation 0	91.7 Hours Geometric Coefficient of Variation 24

Adverse Events

Part A: Dose Escalation

Serious events: 10 serious events

Other events: 18 other events

Deaths: 14 deaths

Part B: Dose Expansion Cohort

Serious events: 16 serious events

Other events: 29 other events

Deaths: 29 deaths

Part C: Dose Expansion Cohort

Serious events: 10 serious events

Other events: 13 other events

Deaths: 13 deaths

Part D: Dose Expansion Cohort

Serious events: 7 serious events

Other events: 12 other events

Deaths: 9 deaths

Part E: Dose Expansion Cohort

Serious events: 6 serious events

Other events: 16 other events

Deaths: 15 deaths

Part F: Dose Expansion Cohort

Serious events: 7 serious events

Other events: 20 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Dose Escalation n=20 participants at risk Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004 - 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort n=29 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort n=13 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort n=12 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort n=17 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort n=20 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Cardiac disorders Myocardial infarction	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Ascites	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Pancreatic cyst	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Subileus	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Asthenia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders General physical health deterioration	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Performance status decreased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Hepatobiliary disorders Cholangitis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Hepatobiliary disorders Jaundice	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	16.7% 2/12 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Immune system disorders Hypersensitivity	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Abdominal abscess	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Esophageal candidiasis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Peritonitis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Sepsis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Urinary tract infection	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Catheter site infection	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Endocarditis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Injury, poisoning and procedural complications Fracture	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Injury, poisoning and procedural complications Infusion related reaction	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Injury, poisoning and procedural complications Spinal fracture	5.0% 1/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Blood bilirubin increased	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypomagnesemia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	13.8% 4/29 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	20.0% 4/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	35.0% 7/20 • Number of events 7 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	31.0% 9/29 • Number of events 9 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	46.2% 6/13 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	33.3% 4/12 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Nervous system disorders Spinal cord compression	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Renal and urinary disorders Obstructive uropathy	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Renal and urinary disorders Renal failure acute	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Respiratory, thoracic and mediastinal disorders Bronchospasm	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Dermatitis acneiform	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Vascular disorders Shock	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Vascular disorders Hypovolemic shock	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.

Other adverse events

Other adverse events
Measure	Part A: Dose Escalation n=20 participants at risk Dose escalation in patients with refractory or recurrent advanced solid tumors. Sym004 - 0.4 mg/kg, 0.75 mg/kg, 1.5 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, 12 mg/kg, weekly - i.v. infusions	Part B: Dose Expansion Cohort n=29 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 12 mg/kg, weekly - i.v. infusions	Part C: Dose Expansion Cohort n=13 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 9 mg/kg, weekly - i.v. infusions	Part D: Dose Expansion Cohort n=12 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 12 mg/kg, once every 2 weeks - i.v. infusions	Part E: Dose Expansion Cohort n=17 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 18 mg/kg, once every 2 weeks - i.v. infusions	Part F: Dose Expansion Cohort n=20 participants at risk Dose expansion cohort in patients with advanced anti-EGFR antibody refractory mCRC. Sym004 - 9 mg/kg loading dose followed by 6 mg/kg, weekly - i.v. infusions
Renal and urinary disorders Leukocyturia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Renal and urinary disorders Urinary incontinence	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Rash	40.0% 8/20 • Number of events 9 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	79.3% 23/29 • Number of events 26 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	76.9% 10/13 • Number of events 13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	91.7% 11/12 • Number of events 12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	94.1% 16/17 • Number of events 17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	90.0% 18/20 • Number of events 26 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Dry skin	45.0% 9/20 • Number of events 9 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	48.3% 14/29 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	38.5% 5/13 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	16.7% 2/12 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	29.4% 5/17 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Pruritus	30.0% 6/20 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	44.8% 13/29 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	38.5% 5/13 • Number of events 7 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	41.2% 7/17 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	25.0% 5/20 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Skin fissures	20.0% 4/20 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	34.5% 10/29 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	30.8% 4/13 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	16.7% 2/12 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	50.0% 10/20 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Erythema	5.0% 1/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	24.1% 7/29 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.1% 3/13 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Dermatitis acneiform	30.0% 6/20 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	17.2% 5/29 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Hypertrichosis	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.3% 3/29 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Nail toxicity	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Pain of skin	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Rash maculo-papular	15.0% 3/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Scab	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Acne	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Asthenia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	24.1% 7/29 • Number of events 11 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	53.8% 7/13 • Number of events 10 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	58.3% 7/12 • Number of events 11 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	41.2% 7/17 • Number of events 10 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	40.0% 8/20 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Mucosal inflammation	30.0% 6/20 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	34.5% 10/29 • Number of events 16 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	30.8% 4/13 • Number of events 7 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.5% 4/17 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	25.0% 5/20 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Xerosis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	27.6% 8/29 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.4% 2/13 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	29.4% 5/17 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Edema peripheral	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	13.8% 4/29 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.1% 3/13 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	16.7% 2/12 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Fatigue	15.0% 3/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	13.8% 4/29 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Edema	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Chills	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Device occlusion	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
General disorders Pyrexia	5.0% 1/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.3% 3/29 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	35.0% 7/20 • Number of events 10 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Diarrhea	30.0% 6/20 • Number of events 9 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	34.5% 10/29 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	53.8% 7/13 • Number of events 13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	33.3% 4/12 • Number of events 7 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	58.8% 10/17 • Number of events 20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	35.0% 7/20 • Number of events 12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Nausea	15.0% 3/20 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	27.6% 8/29 • Number of events 13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.1% 3/13 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	33.3% 4/12 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Vomiting	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	17.2% 5/29 • Number of events 9 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	30.8% 4/13 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	25.0% 3/12 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Constipation	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	13.8% 4/29 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.4% 2/13 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	17.6% 3/17 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	20.0% 4/20 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.3% 3/29 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	25.0% 3/12 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Dyspepsia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Stomatitis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Ascites	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Hemorrhoids	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Flatulence	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Gastrointestinal disorders Dry mouth	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 5/20 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	58.6% 17/29 • Number of events 19 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	46.2% 6/13 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	58.3% 7/12 • Number of events 9 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	70.6% 12/17 • Number of events 15 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	45.0% 9/20 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	31.0% 9/29 • Number of events 9 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	38.5% 5/13 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	33.3% 4/12 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	20.0% 4/20 • Number of events 6 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	34.5% 10/29 • Number of events 11 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	20.0% 4/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypokalemia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.1% 3/13 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	16.7% 2/12 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hyperkalemia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Paronychia	15.0% 3/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	31.0% 9/29 • Number of events 15 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.4% 2/13 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	16.7% 2/12 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.5% 4/17 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Superinfection	10.0% 2/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	20.7% 6/29 • Number of events 8 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Urinary tract infection	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Nasopharyngitis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Respiratory tract infection	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Gastroenteritis	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Skin infection	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Upper respiratory tract infection	10.0% 2/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Fungal infection	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Infections and infestations Nail infection	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	17.6% 3/17 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Alanine aminotransferase increased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Blood alkaline phosphatase increase	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Blood magnesium decreased	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Hemoglobin decreased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Body temperature decreased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Amylase increased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Blood albumin decreased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Lipase increased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Blood creatinine increased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Investigations Platelet count decreased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Eye disorders Conjunctivitis	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	34.5% 10/29 • Number of events 14 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.4% 2/13 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.5% 4/17 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Eye disorders Dry eye	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Eye disorders Blepharitis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.4% 2/13 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Eye disorders Lacrimation increased	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Eye disorders Ocular icterus	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Back pain	10.0% 2/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	15.0% 3/20 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Muscle spasms	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.0% 3/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	17.2% 5/29 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	23.1% 3/13 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.3% 3/29 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Nervous system disorders Headache	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 5 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Nervous system disorders Dysgeusia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	17.6% 3/17 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Nervous system disorders Neuropathy peripheral	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Injury, poisoning and procedural complications Infusion related reaction	15.0% 3/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Blood and lymphatic system disorders Anemia	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	13.8% 4/29 • Number of events 4 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	17.6% 3/17 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	11.8% 2/17 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Hepatobiliary disorders Hepatic pain	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Psychiatric disorders Insomnia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.3% 3/29 • Number of events 3 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Psychiatric disorders Depression	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Psychiatric disorders Anxiety	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	5.0% 1/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	7.7% 1/13 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor associated fever	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Immune system disorders Hypersensitivity	5.0% 1/20 • Number of events 11 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.0% 1/20 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Vascular disorders Hypertension	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	3.4% 1/29 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Congenital, familial and genetic disorders Trichomegaly	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	6.9% 2/29 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	10.0% 2/20 • Number of events 2 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	8.3% 1/12 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/17 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Reproductive system and breast disorders Pruritus genital	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.
Renal and urinary disorders Dysuria	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/29 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/13 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/12 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	5.9% 1/17 • Number of events 1 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.	0.00% 0/20 • The Adverse Event (AE) reporting period for non-serious AEs started at Visit 2 (first dosing visit) and lasted until the first Follow-up Visit (4 weeks following last dose) or end of trial if the patient was withdrawn from the trial without the Follow-up Visits being performed. The AE reporting period for Serious Adverse Events (SAEs) started when the patient signed the informed consent and lasted until termination of the trial. Any non-serious signs or symptoms occurring between Visit 1 and start of treatment at Visit 2 were recorded as medical history. In the survival period after end of trial, only SAEs with fatal outcome and SAEs considered related to Sym004 by the Investigator were collected.

Additional Information

Chief Scientific Officer

Symphogen A/S

Phone: +45 8838 2600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place