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. 2022 Feb 23;16:485–497. doi: 10.2147/DDDT.S334960

Table 2.

Number of Individuals Who Reported at Least One AE During (A) the Single Ascending Dose Part and (B) the Multiple Ascending Dose Part of the Study

A:
Summary of number (%) of participants who had at least 1 adverse event in any category
Velsecorat
Adverse event category Pooled placebo
N=12 		7 µg
N=6 		38 µg
N=6 		187 µg
N=6 		624 µg
N=5 		1248 µg
N=6 		1872 µg
N=6 		All velsecorat
N=35
Any AE 3 (25.0) 1 (16.7) 1 (16.7) 1 (16.7) 1 (20.0) 2 (33.3) 1 (16.7) 7 (20.0)
Any serious AE (including events with outcome=death) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Summary of number (%) of participants who had at least 1 adverse event, by Preferred Term, arranged by System Organ Class
System Organ Class Preferred Term Pooled placebo
N=12 		7 µg
N=6 		38 µg
N=6 		187 µg
N=6 		624 µg
N=5 		1248 µg
N=6 		1872 µg
N=6 		All velsecorat
N=35
Ear and labyrinth disorders 1 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Ear pain 1 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Gastrointestinal disorders 1 (8.3) 1 (16.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.9)
 Abdominal discomfort 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Salivary hypersecretion 1 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Infections and infestations 1 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.9)
 Nasopharyngitis 1 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Rhinitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0)
Musculoskeletal and connective tissue disorders 0 (0.0) 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.9)
Musculoskeletal chest pain 0 (0.0) 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.9)
B:
Summary of number (%) of participants who had at least 1 adverse event in any category
Velsecorat
Adverse event category Pooled placebo N=9 312 µg
N=6 		1248 µg
N=5 		1872 µg
N=6 		All AZD7594
N=17
Any AE 6 (66.7) 3 (50.0) 1 (20.0) 3 (50.0) 7 (41.2)
Any serious AE (including events with outcome=death) 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 1 (5.9)
Summary of number (%) of subjects who had at least 1 adverse event, by Preferred Term, arranged by System Organ Class
System Organ Class Preferred Term Pooled placebo N=9 312 µg
N=6 		1248 µg
N=5 		1872 µg
N=6 		All AZD7594
N=17
Gastrointestinal disorders 3 (33.3) 3 (50.0) 0 (0.0) 1 (16.7) 4 (23.5)
 Abdominal pain 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 0 (0.0)
 Diarrhea 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 1 (5.9)
 Dyspepsia 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Gingival bleeding 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 1 (5.9)
 Mouth ulceration 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 1 (5.9)
 Nausea 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 1 (5.9)
 Oral pain 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Toothache 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
General disorders and administration site conditions 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Local swelling 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Infections and infestations 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Nasopharyngitis 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Musculoskeletal and connective tissue disorders 2 (22.2) 0 (0.0) 0 (0.0) 1 (16.7) 1 (5.9)
 Muscle twitching 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Myalgia 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 1 (5.9)
 Pain in extremity 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Nervous system disorders 4 (44.4 ) 0 (0.0) 1 (20.0) 1 (16.7) 2 (11.8)
 Headache 4 (44.4) 0 (0.0) 0 (0.0) 1 (16.7) 1 (5.9)
 Dizziness 0 (0.0) 0 (0.0) 1 (20.0) 0 (0.0) 1 (5.9)
 Dysgeusia 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Psychiatric disorders 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Restlessness 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Respiratory, thoracic, and mediastinal disorders 2 (22.2) 2 (33.3) 0 (0.0) 0 (0.0) 2 (11.8)
 Dyspnea 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Hiccups 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 1 (5.9)
 Oropharyngeal pain 0 (0.0) 1 (16.7) 0 (0.0) 0 (0.0) 1 (5.9)
 Rhinorrhea 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Sneezing 1 (11.1) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Vascular disorders 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 1 (5.9)
 Thrombosisa 0 (0.0) 0 (0.0) 0 (0.0) 1 (16.7) 1 (5.9)