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Table 3 Treatment-emergent AEs by system organ class and preferred term (safety population). Observed in ≥2 subjects in the a) SAD and b) MAD study

From: Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers

System organ class Preferred term Single ascending dose
500 mg (n = 8) n (%) 1000 mg (n = 8) n (%) 2000 mg (n = 8) n (%) 4000 mg (n = 8) n (%) Placebo (n = 8) n (%)
At least one TEAE 3 (37.5) 0 5 (62.5) 3 (37.5) 2 (25.0)
Gastrointestinal disorders 2 (25.0) 0 3 (37.5) 1 (12.5) 1 (12.5)
 Diarrhea 1 (12.5) 0 3 (37.5) 1 (12.5) 0
Infections and infestations 0 0 0 2 (25.0) 0
Investigations 0 0 1 (12.5) 1 (12.5) 0
 Transaminase increased 0 0 1 (12.5) 1 (12.5) 0
System organ class Preferred term Multiple ascending dose
250 mg BID (n = 8) n (%) 500 mg BID (n = 8) n (%) 1000 mg BID (n = 8) n (%) Placebo (n = 6) n (%)
At least one TEAE 4 (50.0) 6 (75.0) 5 (62.5) 3 (50.0)
Nervous system disorders 2 (25.0) 1 (12.5) 2 (25.0) 2 (33.3)
 Headache 1 (12.5) 1 (12.5) 0 2 (33.3)
Gastrointestinal disorders 2 (25.0) 0 2 (25.0) 3 (50.0)
Respiratory, thoracic, and mediastinal disorders 0 2 (25.0) 2 (25.0) 0
 Oropharyngeal pain 0 1 (12.5) 1 (12.5) 0
General disorders and administration- site conditions 0 0 2 (25.0) 1 (16.7)
Infections and infestations 0 1 (12.5) 1 (12.5) 0
Musculoskeletal and connective tissue disorders 2 (25.0) 2 (25.0) 0 0
 Back pain 1 (12.5) 1 (12.5) 0 0
Skin and subcutaneous tissue disorders 0 1 (12.5) 1 (12.5) 0
 Pruritus 0 1 (12.5) 1 (12.5) 0
  1. BID Twice daily, MAD multiple ascending oral dose; SAD single ascending dose; TEAE Treatment-emergent adverse advent