TABLE 3.
MAD study adverse events by treatment. All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 20.0. Light blue rows depict system organ classes and numbers are a summation of all preferred terms in that class. Multiple AEs could be reported by the same subject
| MAD adverse events | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 3 mg LTI‐291 | 10 mg LTI‐291 | 30 mg LTI‐291 | 60 mg LTI‐291 | Placebo | ||||||
| n = 7 | n = 8 | n = 8 | n = 8 | n = 8 | ||||||
| System organ class/preferred term | Events (n) | Subjects (n (%)) | Events (n) | Subjects (n (%)) | Events (n) | Subjects (n (%)) | Events (n) | Subjects (n (%)) | Events (n) | Subjects (n (%)) |
| Any events | 17 | 5 (71.4) | 15 | 6 (75.0) | 19 | 7 (87.5) | 27 | 8 (100.0) | 11 | 5 (62.5) |
| Cardiac disorders | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Bundle branch block right | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Eye disorders | – | – | 1 | 1 (12.5) | – | – | 1 | 1 (12.5) | 1 | 1 (12.5) |
| Ocular hyperaemia | – | – | 1 | 1 (12.5) | – | – | – | – | – | – |
| Vision blurred | – | – | – | – | – | – | 1 | 1 (12.5) | 1 | 1 (12.5) |
| Gastrointestinal disorders | 3 | 3 (42.9) | 1 | 1 (12.5) | 3 | 2 (25.0) | 4 | 2 (25.0) | – | – |
| Abdominal pain upper | 1 | 1 (14.3) | 1 | 1 (12.5) | – | – | 1 | 1 (12.5) | – | – |
| Constipation | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Diarrhoea | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Faeces soft | – | – | – | – | – | – | 1 | 1 (12.5) | – | – |
| Flatulence | – | – | – | – | – | – | 1 | 1 (12.5) | – | – |
| Frequent bowel movements | – | – | – | – | 1 | 1 (12.5) | – | – | – | – |
| Nausea | – | – | – | – | 2 | 1 (12.5) | 1 | 1 (12.5) | – | – |
| General disorders and administration site conditions | 4 | 3 (42.9) | 2 | 2 (25.0) | 2 | 2 (25.0) | 3 | 3 (37.5) | 2 | 2 (25.0) |
| Fatigue | 1 | 1 (14.3) | – | – | – | – | – | – | 1 | 1 (12.5) |
| Feeling cold | – | – | – | – | – | – | 1 | 1 (12.5) | – | – |
| Feeling hot | – | – | 1 | 1 (12.5) | – | – | – | – | – | – |
| Medical device site eczema | – | – | – | – | 1 | 1 (12.5) | – | – | 1 | 1 (12.5) |
| Medical device site erythema | – | – | – | – | – | – | 1 | 1 (12.5) | – | – |
| Medical device site reaction | 2 | 2 (28.6) | – | – | 1 | 1 (12.5) | – | – | – | – |
| Pain | – | – | – | – | – | – | 1 | 1 (12.5) | – | – |
| Puncture site pain | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Vessel puncture site vesicles | – | – | 1 | 1 (12.5) | – | – | – | – | – | – |
| Infections and infestations | 1 | 1 (14.3) | – | – | – | – | 1 | 1 (12.5) | – | – |
| Nasopharyngitis | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Urinary tract infection | – | – | – | – | – | – | 1 | 1 (12.5) | – | – |
| Investigations | 1 | 1 (14.3) | 1 | 1 (12.5) | – | – | 1 | 1 (12.5) | – | – |
| Gamma‐glutamyltransferase increased | – | – | – | – | – | – | 1 | 1 (12.5) | – | – |
| Hepatic enzyme increased | 1 | 1 (14.3) | 1 | 1 (12.5) | – | – | – | – | – | – |
| Musculoskeletal and connective tissue disorders | 1 | 1 (14.3) | 4 | 4 (50.0) | 4 | 2 (25.0) | 9 | 6 (75.0) | 5 | 4 (50.0) |
| Arthralgia | – | – | – | – | 2 | 2 (25.0) | – | – | – | – |
| Back pain | – | – | 2 | 2 (25.0) | – | – | 2 | 2 (25.0) | 2 | 2 (25.0) |
| Muscle fatigue | – | – | 1 | 1 (12.5) | – | – | 1 | 1 (12.5) | – | – |
| Muscle spasms | – | – | – | – | 1 | 1 (12.5) | 2 | 2 (25.0) | – | – |
| Musculoskeletal stiffness | – | – | – | – | – | – | 1 | 1 (12.5) | 1 | 1 (12.5) |
| Myalgia | 1 | 1 (14.3) | – | – | 1 | 1 (12.5) | 3 | 3 (37.5) | 1 | 1 (12.5) |
| Neck pain | – | – | 1 | 1 (12.5) | – | – | – | – | – | – |
| Pain in extremity | – | – | – | – | – | – | – | – | 1 | 1 (12.5) |
| Nervous system disorders | 4 | 3 (42.9) | 3 | 2 (25.0) | 6 | 5 (62.5) | 8 | 5 (62.5) | 3 | 3 (37.5) |
| Dizziness | 1 | 1 (14.3) | – | – | 1 | 1 (12.5) | – | – | 2 | 2 (25.0) |
| Head discomfort | – | – | 1 | 1 (12.5) | – | – | 1 | 1 (12.5) | – | – |
| Headache | 2 | 2 (28.6) | 2 | 2 (25.0) | 5 | 5 (62.5) | 3 | 3 (37.5) | – | – |
| Somnolence | 1 | 1 (14.3) | – | – | – | – | 4 | 4 (50.0) | 1 | 1 (12.5) |
| Renal and urinary disorders | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Polyuria | 1 | 1 (14.3) | – | – | – | – | – | – | – | – |
| Respiratory, thoracic and mediastinal disorders | 1 | 1 (14.3) | 1 | 1 (12.5) | 2 | 1 (12.5) | – | – | – | – |
| Nasal congestion | 1 | 1 (14.3) | 1 | 1 (12.5) | 1 | 1 (12.5) | – | – | – | – |
| Oropharyngeal pain | – | – | – | – | 1 | 1 (12.5) | – | – | – | – |
| Skin and subcutaneous tissue disorders | – | – | 1 | 1 (12.5) | 2 | 1 (12.5) | – | – | – | – |
| Hyperhidrosis | – | – | 1 | 1 (12.5) | 2 | 1 (12.5) | – | – | – | – |
| Vascular disorders | – | – | 1 | 1 (12.5) | – | – | – | – | – | – |
| Hypertension | – | – | 1 | 1 (12.5) | – | – | – | – | – | – |