Table 4.
Phase 1a single-dose BTH1677 study: Subjects with all and treatment-related adverse events by treatment group
| System Organ Class and Preferred Term a,b | Treatment Group | |||||||
|---|---|---|---|---|---|---|---|---|
| BTH1677 | Placebo | |||||||
| 0.5 mg/kg (1-h infusion) (n = 3) | 1 mg/kg (1-h infusion) (n = 3) | 2 mg/kg (1-h infusion) (n = 4) | 4 mg/kg (1-h infusion) (n = 2) | 4 mg/kg (2-h infusion) (n = 3) | 6 mg/kg (3-h infusion) (n = 3) | All BTH1677 (n = 18) | All Placeboc (n = 6) | |
| Subjects with any AE/Treatment-related AE | 3/2 | 1/1 | 2/1 | 2/2 | 1/0 | 3/3 | 12/9 | 3/0 |
| Cardiac disorders | 0/0 | 0/0 | 0/0 | 1/1 | 0/0 | 0/0 | 1/1 | 0/0 |
| Tachycardia | 0/0 | 0/0 | 0/0 | 1/1d | 0/0 | 0/0 | 1/0 | 0/0 |
| Eye disorders | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 |
| Photophobia | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 |
| Gastrointestinal disorders | 0/0 | 0/0 | 0/0 | 1/1 | 0/0 | 1/1 | 2/2 | 1/0 |
| Nausea | 0/0 | 0/0 | 0/0 | 1/1d | 0/0 | 1/1 | 2/2 | 0/0 |
| Diarrhea | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 |
| Flatulence | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 |
| Gingival pain | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 |
| Toothache | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 |
| General disorders and administration site conditions | 0/0 | 1/1 | 0/0 | 0/0 | 0/0 | 2/2 | 3/3 | 0/0 |
| Chest discomfort | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/1 | 1/1 | 0/0 |
| Chills | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/1 | 1/1 | 0/0 |
| Infusion site pain | 0/0 | 1/1 | 0/0 | 0/0 | 0/0 | 0/0 | 1/1 | 0/0 |
| Infections and infestations | 1/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| Upper respiratory tract infection | 1/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| Injury, poisoning and procedural complications | 0/0 | 0/0 | 1/0 | 0/0 | 1/0 | 0/0 | 2/0 | 0/0 |
| Back injury | 0/0 | 0/0 | 1/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| Laceration | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 | 1/0 | 0/0 |
| Investigations | 0/0 | 0/0 | 0 /0 | 1/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| White blood cell count decreased | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| Musculoskeletal and connective tissue disorders | 0/0 | 0/0 | 1/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| Arthralgia | 0/0 | 0/0 | 1/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| Nervous system disorders | 2/2 | 0/0 | 0/0 | 1/1 | 0/0 | 2/2 | 5/5 | 2/0 |
| Headache | 2/2 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 2/2 | 2/0 |
| Dizziness | 0/0 | 0/0 | 0/0 | 1/1d | 0/0 | 0/0 | 1/1 | 1/0 |
| Paraesthesia | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 2/2d | 2/2 | 0/0 |
| Hypoaesthesia | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/1d | 1/1 | 0/0 |
| Migraine | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 |
| Respiratory, thoracic and mediastinal disorders | 1/0 | 0/0 | 0/0 | 2/2 | 0/0 | 1/1 | 4/3 | 0/0 |
| Dyspnea | 0/0 | 0/0 | 0/0 | 2/2d | 0/0 | 1/1d | 3/3 | 0/0 |
| Throat irritation | 1/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 |
| Skin and subcutaneous tissue disorders | 0/0 | 0/0 | 1/1 | 2/2 | 1/0 | 1/1 | 5/4 | 0/0 |
| Rash | 0/0 | 0/0 | 1/1d | 0/0 | 0/0 | 1/1d | 2/2 | 0/0 |
| Ecchymosis | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/0 | 1/0 | 0/0 |
| Hyperhidrosis | 0/0 | 0/0 | 0/0 | 1/1d | 0/0 | 0/0 | 1/1 | 0/0 |
| Pruritus | 0/0 | 0/0 | 0/0 | 1/1d | 0/0 | 0/0 | 1/1 | 0/0 |
| Vascular disorders | 0/0 | 0/0 | 0/0 | 2/2 | 0/0 | 0/0 | 2/2 | 0/0 |
| Flushing | 0/0 | 0/0 | 0/0 | 2/2d | 0/0 | 0/0 | 2/2 | 0/0 |
AE adverse events
aCoded by Medical Dictionary for Regulatory Activities (MEdDRA; V 8.1) by System Organ Class (SOC) (bolded terms) and preferred term (non-bolded terms).
bData are presented as the number of subjects experiencing any AE and the number of subjects experiencing treatment-related AEs separated by “/”. For both categories, each subject was counted only once for each SOC and each preferred term; a single subject may have had multiple AEs within a specific SOC. Treatment-related AEs included AEs assessed by the investigator as related from the options of not related, related, and unknown.
cFor subjects receiving placebo, infusion time matched that of the corresponding treatment group.
dAEs leading to premature discontinuation from the study (paraesthesia led to discontinuation in only 1 subject).