Table 2.
Study visit | Total number reporting TEAE | TEAE details (number reported) |
---|---|---|
2 weeks | 14 | Sweating (6), heartburn (2), dry mouth (2), nausea (6), decreased appetite at night (2), hot flushes (2), irritability (2), light headedness (2), headache (3), drowsiness and diarrhoea for 3 days, insomnia for 4 days |
4 weeks | 12 | Sweating (5), headache (3), nausea (2), dry mouth (2), muscle tension, hot flushes when not taken with food, light headedness, drowsiness/tiredness at night after meds, nausea for 1 day |
6 weeks | 6 | Sweating (3), headache (4), dry mouth (2), tiredness, hot flushes, low appetite in pm |
8 weeks | 6 | Nausea as a result of increased exercise, dry mouth (3), sweating (4), headache (3) |
10 weeks | 6 | Mild sweating, headache (2), dry mouth (2), nausea for few hours after meds, night sweating since increase to 100 mg |
12 weeks | 8 | Sweating (3), headaches occasional, hot flushes, nausea after meds |
TEAE, treatment-emergent adverse effect.