Trial Outcomes & Findings for Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS (NCT NCT05918978)

NCT ID: NCT05918978

Last Updated: 2025-10-23

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days
• Results posted on: 2025-10-23

Participant Flow

This open-label study was an extension of ARGX-113-2104 study (NCT05633407) and was conducted at 9 sites in the United States from 26-Jun-23 to 15-Aug-24 in participants with post-coronavirus disease 2019 (COVID-19) postural orthostatic tachycardia syndrome (PC-POTS).

A total of 33 participants were rolled over from both active (efgartigimod) and placebo arms of the parent study ARGX-113-2104 (NCT05633407) to receive efgartigimod in this study. This study was terminated not for safety concerns but because the parent study found that efgartigimod intravenous (IV) provided no efficacy benefit in adult participants with PC-POTS.

Participant milestones

Measure	Efgartigimod-Efgartigimod Participants who received efgartigimod in parent study continued to receive efgartigimod 10 milligram/kilogram (mg/kg) via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Placebo-Efgartigimod Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Overall Study STARTED	20	13
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	19	13

Reasons for withdrawal

Measure	Efgartigimod-Efgartigimod Participants who received efgartigimod in parent study continued to receive efgartigimod 10 milligram/kilogram (mg/kg) via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Placebo-Efgartigimod Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Overall Study Study Terminated by Sponsor	17	11
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	1	0
Overall Study Other	0	1

Baseline Characteristics

Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS

Baseline characteristics by cohort

Measure	Efgartigimod-Efgartigimod n=20 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Placebo-Efgartigimod n=13 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Total n=33 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 11.38 • n=5 Participants	38.0 years STANDARD_DEVIATION 11.40 • n=7 Participants	35.1 years STANDARD_DEVIATION 11.46 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days

Population: The safety analysis set (SAF) included all enrolled participants exposed to study drug.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.

Outcome measures

Measure	Placebo-Efgartigimod n=13 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=20 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Number of Participants With TEAEs, TESAEs and TEAESIs TEAEs	12 Participants	13 Participants
Number of Participants With TEAEs, TESAEs and TEAESIs TESAEs	0 Participants	0 Participants
Number of Participants With TEAEs, TESAEs and TEAESIs TEAESIs	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 48

Population: The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported.

Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms.

Outcome measures

Measure	Placebo-Efgartigimod n=7 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=10 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version) Week 24	8.447 score on a scale Standard Deviation 18.1170	13.608 score on a scale Standard Deviation 29.7026
Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version) Week 48	—	1.780 score on a scale

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 48

Population: The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported.

The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a numerical rating scale ranging from 0 (no symptoms) to 10 (very pronounced symptoms). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms.

Outcome measures

Measure	Placebo-Efgartigimod n=6 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=8 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Change From Baseline to Weeks 24 and 48 in the MaPS Week 24	10.3 score on a scale Standard Deviation 24.95	-0.8 score on a scale Standard Deviation 22.02
Change From Baseline to Weeks 24 and 48 in the MaPS Week 48	—	-17.0 score on a scale

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 48

Population: The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported.

The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An "improved PGI-S" was defined by a change from baseline of -3, -2 and -1.

Outcome measures

Measure	Placebo-Efgartigimod n=5 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=8 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Percentage of Participants With Improved PGI-S at Weeks 24 and 48 Week 24, 1-week recall	0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Improved PGI-S at Weeks 24 and 48 Week 24, 2-week recall	0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Improved PGI-S at Weeks 24 and 48 Week 48, 1-week recall	0 percentage of participants	25.0 percentage of participants
Percentage of Participants With Improved PGI-S at Weeks 24 and 48 Week 48, 2-week recall	0 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 48

Population: The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported.

The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of an overall change in their symptoms from start of study drug. It was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An "improved PGI-C" was defined by a change from baseline of 1, 2 and 3.

Outcome measures

Measure	Placebo-Efgartigimod n=5 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=8 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Percentage of Participants With Improved PGI-C at Weeks 24 and 48 Week 24	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With Improved PGI-C at Weeks 24 and 48 Week 48	75.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 48

Population: The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue.

Outcome measures

Measure	Placebo-Efgartigimod n=5 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=8 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a Week 24	2.6 T-score Standard Deviation 9.74	3.0 T-score Standard Deviation 4.93
Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a Week 48	1.0 T-score Standard Deviation 5.94	-3.5 T-score Standard Deviation 3.42

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 48

Population: The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported.

PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function.

Outcome measures

Measure	Placebo-Efgartigimod n=7 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=10 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Change From Baseline to Weeks 24 and 48 in the PROMIS Cognitive Function Short Form 6a Week 24	-4.0 T-score Standard Deviation 5.97	-2.2 T-score Standard Deviation 7.36
Change From Baseline to Weeks 24 and 48 in the PROMIS Cognitive Function Short Form 6a Week 48	—	-8.0 T-score

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 48

Population: The SAF included all enrolled participants exposed to study drug. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported.

Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory.

Outcome measures

Measure	Placebo-Efgartigimod n=4 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=8 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Percent Change From Baseline in Total IgG Levels at Weeks 24 and 48 Week 24	-59.636 percent change Standard Deviation 6.2440	32.684 percent change Standard Deviation 28.6347
Percent Change From Baseline in Total IgG Levels at Weeks 24 and 48 Week 48	—	-10.360 percent change

SECONDARY outcome

Timeframe: Pre-dose at Baseline (Day 1) and Weeks 1, 4, 12 and 24

Population: The pharmacokinetic analysis set (PKAS) included all enrolled participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentration. Only those participants with data collected at specified timepoints are reported.

Serum samples were collected at specified timepoints to determine the concentration of efgartigimod.

Outcome measures

Measure	Placebo-Efgartigimod n=9 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=18 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Serum Concentration of Efgartigimod Week 1	11 microgram/milliliter (mcg/mL) Standard Deviation 4	10 microgram/milliliter (mcg/mL) Standard Deviation 4
Serum Concentration of Efgartigimod Week 4	12 microgram/milliliter (mcg/mL) Standard Deviation 4	11 microgram/milliliter (mcg/mL) Standard Deviation 4
Serum Concentration of Efgartigimod Week 12	7 microgram/milliliter (mcg/mL) Standard Deviation 6	3 microgram/milliliter (mcg/mL) Standard Deviation 3
Serum Concentration of Efgartigimod Week 24	2 microgram/milliliter (mcg/mL) Standard Deviation 2	5 microgram/milliliter (mcg/mL) Standard Deviation 5
Serum Concentration of Efgartigimod Day 1	—	9 microgram/milliliter (mcg/mL) Standard Deviation 4

SECONDARY outcome

Timeframe: From the first dose of study drug (Day 1) up to Week 48

Population: The SAF included all enrolled participants exposed to study drug.

Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline.

Outcome measures

Measure	Placebo-Efgartigimod n=13 Participants Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Efgartigimod-Efgartigimod n=20 Participants Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Number of Participants With ADAs Against Efgartigimod	1 Participants	1 Participants

Adverse Events

Efgartigimod-Efgartigimod

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo-Efgartigimod

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Efgartigimod-Efgartigimod n=20 participants at risk Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).	Placebo-Efgartigimod n=13 participants at risk Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period).
Cardiac disorders Palpitations	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Ear and labyrinth disorders Ear discomfort	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Ear and labyrinth disorders Ear pain	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Ear and labyrinth disorders Tinnitus	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Ear and labyrinth disorders Vertigo	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Eye disorders Eye irritation	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Eye disorders Vision blurred	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Number of events 3 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Gastrointestinal disorders Nausea	15.0% 3/20 • Number of events 5 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	15.4% 2/13 • Number of events 3 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 3 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
General disorders Energy increased	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
General disorders Fatigue	10.0% 2/20 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	23.1% 3/13 • Number of events 6 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
General disorders Injection site bruising	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
General disorders Non-cardiac chest pain	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
General disorders Pyrexia	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Immune system disorders Contrast media reaction	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Infections and infestations Bronchitis	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Infections and infestations COVID-19	25.0% 5/20 • Number of events 5 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Infections and infestations Gastrointestinal bacterial overgrowth	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Infections and infestations Helicobacter infection	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Infections and infestations Laryngitis	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Infections and infestations Nasopharyngitis	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Infections and infestations Urinary tract infection	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Injury, poisoning and procedural complications Arthropod sting	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Injury, poisoning and procedural complications Nerve injury	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Injury, poisoning and procedural complications Vascular access site pain	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Activated partial thromboplastin time shortened	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Blood creatinine increased	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Blood glucose increased	5.0% 1/20 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Blood thyroid stimulating hormone decreased	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Blood urea increased	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Heart rate increased	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Platelet count decreased	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Weight decreased	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations Weight increased	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Investigations White blood cell count decreased	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Metabolism and nutrition disorders Decreased appetite	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Musculoskeletal and connective tissue disorders Back pain	10.0% 2/20 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	15.4% 2/13 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Nervous system disorders Dizziness	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 3 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Nervous system disorders Headache	10.0% 2/20 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Nervous system disorders Migraine	5.0% 1/20 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Nervous system disorders Paraesthesia	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Nervous system disorders Syncope	10.0% 2/20 • Number of events 3 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Psychiatric disorders Insomnia	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 4 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 2/20 • Number of events 2 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Skin and subcutaneous tissue disorders Skin tightness	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Skin and subcutaneous tissue disorders Urticaria	5.0% 1/20 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	0.00% 0/13 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Vascular disorders Vasodilatation	0.00% 0/20 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.	7.7% 1/13 • Number of events 1 • From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.

Additional Information

Regulatory Manager

argenx BVBA

Phone: +32 93103400

Email: regulatory@argenx.com

Results disclosure agreements

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