General disorders and administration site conditions
3
Ankle edema
1
Erythema
1
Limb edema
1
Infections and infestations
3
Herpes simplex infection
1
1
Shingles
1
Musculoskeletal and connective tissue disorders
2
Arthralgia
1
1
Nervous system disorders
12
Lethargy
8
4
Psychiatric disorders
2
Insomnia
1
1
Total number of drug-related side effects
18
10
Total number of patients with drug-related side effects (%)
12/19 (63.16)
8/12 (66.67)
Total number of patients with serious drug-related side effects (%)
0/19 (0.00)
0/12 (0.00)
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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