Adverse event profile after administration of multiple doses of LY2886721
Adverse event | Number of adverse events (subjects) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo (n = 20) | LY2886721 (n = 35) | |||||||||||
5 mg (n = 10) | 15 mg (n = 10) | 35 mg (n = 9) | 70 mg (n = 6) | All doses (n = 35) | ||||||||
Tot | Rel | Tot | Rel | Tot | Rel | Tot | Rel | Tot | Rel | Tot | Rel | |
Headache | 2 (1) | 1 (1) | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 1 (1) | 0 (0) | 0 | 1 (1) | 1 (1) |
Procedural headache | 2 (2)* | 0 | 0 (0) | 0 | 1 (1) | 0 | 0 (0) | 0 | 1 (1) | 0 | 2 (2) | 0 |
Cough | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 1 (1) | 0 |
Dry mouth | 1 (1) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 |
Gingivitis | 1 (1) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 |
Insomnia | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 1 (1) | 0 |
Visual field tests abnormal | 1 (1) | 0 | 1 (1) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 |
Orthostatic hypotension | 0 (0) | 0 | 1 (1) | 1 (1) | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 1 (1) |
Muscle spasms | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 |
Libido decreased | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 1 (1) | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 1 (1) |
Rash | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 1 (1) | 0 |
Scotoma | 1 (1) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 |
Sinus congestion | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 |
Chest pain | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 0 (0) | 0 | 1 (1) | 0 |
Oral herpes | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 0 (0) | 0 | 1 (1) | 0 |
URI | 1 (1) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 |
Viral infection | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (1) | 0 | 0 (0) | 0 | 1 (1) | 0 |
Adverse event, all-cause and related to study drug, by treatment, in order of frequency.
Rel, Related to study drug; Tot, total; URI, upper respiratory tract infection.
↵*Only this adverse event was moderate in severity and all others were mild in severity. None was considered severe.