General disorders and administration site conditions
4
Ankle edema
2
Erythema
1
Limb edema
1
Infections and infestations
7
Herpes simplex infection
1
1
Hordeolum
1
Inguinal abscess
1
SARS-CoV-2 infection
1
Shingles
1
Vaginal mycosis
1
Injury, poisoning, and procedural complications
1
Sprain
1
Investigations
2
Increased intraocular pressure
1
1
Musculoskeletal and connective tissue disorders
5
Arthralgia
1
2
Groin pain
1
Myalgia
1
Nervous system disorders
22
Autoimmune encephalomyelitis#
1
Dizziness
1
Headache
6
Lethargy
8
4
Paresis
1
Paresthesia
1
Psychiatric disorders
2
Insomnia
1
1
Reproductive system and breast disorders
3
Irregular menstruation
3
Skin and subcutaneous tissue disorders
1
Neurodermatitis
1
Vascular disorders
2
Hypertension
1
1
Total number of adverse events
38
23
Total number of patients with adverse events (%)
15/19 (78.95)
11/12 (91.67)
Total number of patients with serious adverse events (%)
2/19 (10.52)
0/12 (0.00)
# Adverse event classified as serious adverse event. n: number of patients/events. LLT: lower limit term; mAb: monoclonal antibody; MedDRA: Medical Dictionary for Regulatory Activities; SOC: system organ class
GJK consults for Immunovant, Inc., New York City, NY, USA. The other authors declare that they have no conflicts of interest.
Ethical approval
The ASCEND GO 2 study was approved by the leading Ethics Committee (Rhineland Palatinate, 2019-14297-AMG).
Consent to participate
Informed consent to participate in the study was obtained from all participants.
Consent to publication
Not applicable.
Availability of data and materials
The raw data supporting the conclusions of this manuscript will be made available by the authors, without undue reservation, to any qualified researcher.
Funding
The JGU Medical Center receives research-associated funding from Immunovant, Inc., New York City, NY, USA [lmmunovant IMV-02524]. The funders had no role in the design of the submitted study, data collection and analysis, decision to publish, or preparation of the manuscript.
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