Table 3.
Part 1 (Cohorts 1–6) trabodenoson dose groups | ||||||||
---|---|---|---|---|---|---|---|---|
System Organ Class Preferred Term | Placebo (n = 24) | 200 μg (n = 6) | 400 μg (n = 6) | 800 μg (n = 6) | 1,600 μg (n = 6) | 2,400 μg (n = 6) | 3,200 μg (n = 6) | Overall N = 36 |
Nervous system disorders | ||||||||
Headache | 8 (33.3) | 4 (66.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 9 (25.0) |
Eye disorders | ||||||||
Eye pain | 1 (4.2) | 2 (33.3) | 1 (16.7) | — | — | — | 1 (16.7) | 4 (11.1) |
Photophobia | — | — | — | — | — | — | — | — |
Pruritus | — | — | — | — | — | — | — | — |
Musculoskeletal and connective tissue disorders | ||||||||
Back pain | 4 (16.7) | — | — | 1 (16.7) | — | 1 (16.7) | — | 2 (5.6) |
Skin and subcutaneous tissue disorders | ||||||||
Cheilitis | — | — | — | — | — | — | — | — |
Dermatitis | — | — | — | 1 (16.7) | — | — | 1 (16.7) | 2 (5.6) |
Gastrointestinal disorders | ||||||||
Constipation | — | — | — | — | — | — | — | — |
Injury, poisoning, and procedural complications | ||||||||
Excoriation | 4 (16.7) | 1 (16.7) | — | 1 (16.7) | — | — | 1 (16.7) | 3 (8.3) |
Vessel puncture site hematoma | — | — | — | — | — | — | — | — |
Vessel puncture site pain | — | — | — | — | — | — | — | — |