Table 5 Reported incidence of adverse events, by treatment group, by at Least 1 Subject Treated with MSI-195 or SAM-e Complete™ for stages 1 and 2
Stage 1 | Stage 2 | |||||
|---|---|---|---|---|---|---|
Body System/ Adverse Event | MSI-195 400 mg (N = 8) | MSI-195 800 mg (N = 8) | MSI-195 1600 mg (N = 8) | MSI-195 800 mg (N = 26) Fasted | SAM-e Complete™ 1600 mg (N = 24) | MSI-195 800 mg (N = 24) Fed |
Subjects with at least one AE [n(%)] | 2 ( 25.0) | 0 | 4 ( 50.0) | 12 ( 46.2) | 11 ( 45.8) | 11 ( 45.8) |
GASTROINTESTINAL DISORDERS [n(%)] | 2 ( 25.0) | 0 | 4 ( 50.0) | 7 ( 26.9) | 5 ( 20.8) | 4 ( 16.7) |
Abdominal Pain Upper [n(%)] | 0 | 0 | 3 ( 37.5) | 0 | 0 | 0 |
Abdominal Pain [n(%)] | 1 ( 12.5) | 0 | 1 ( 12.5) | 2 ( 7.7) | 1 ( 4.2) | 2 ( 8.3) |
Abdominal Pain, Lower [n (%)] | 1 ( 3.8) | 2 ( 8.3) | 0 | |||
Flatulence [n(%)] | 1 ( 12.5) | 0 | 1 ( 12.5) | 0 | 0 | 0 |
Abdominal Discomfort [n(%)] | 1 ( 12.5) | 0 | 0 | 1 (3.8) | 1 (4.2) | 1 (4.2) |
Abnormal Faeces [n(%)] | 0 | 0 | 0 | 0 | 1 ( 4.2) | 0 |
Dyspepsia [n(%)] | 0 | 0 | 0 | 1 ( 3.8) | 0 | 0 |
Lip Dry [n(%)] | 0 | 0 | 0 | 1 ( 3.8) | 0 | 0 |
Vomiting [n(%)] | 0 | 0 | 0 | 1 ( 3.8) | 0 | 0 |
Eructation [n(%)] | 0 | 0 | 1 ( 12.5) | 0 | 0 | 0 |
Nausea [n(%)] | 0 | 0 | 1 ( 12.5) | 4 ( 15.4) | 2 ( 8.3) | 1 ( 4.2) |
NERVOUS SYSTEM DISORDERS [n(%)] | 1 ( 12.5) | 0 | 2 ( 25.0) | 3 ( 11.5) | 4 ( 16.7) | 8 ( 33.3) |
Dizziness [n(%)] | 1 ( 12.5) | 0 | 2 ( 25.0) | 1 ( 3.8) | 1 ( 4.2) | 0 |
Somnolence [n(%)] | 0 | 0 | 0 | 2 ( 7.7) | 2 ( 8.3) | 6 ( 25.0) |
Headache [n(%)] | 0 | 0 | 0 | 1 ( 3.8) | 2 ( 8.3) | 4 ( 16.7) |
Dysgeusia [n(%)] | 0 | 0 | 0 | 0 | 1 ( 4.2) | 1 ( 4.2) |
Presyncope [n(%)] | 0 | 0 | 0 | 1 (3.8) | 0 | 0 |