Table 3 Frequency of the most commonly reported adverse drug reactions (ADRs) by treatment group and symptom category.
Adverse drug reactions (ADRs) | Entire cohort | Inadequate drug level | Unadjusted dose | Adjusted dose | |
|---|---|---|---|---|---|
Autonomous nervous system | Dry mouth | 11/60 | 2/13 | 2/19 | 7/60 |
Increased sweating | 5/92 | 0/13 | 0/19 | 5/60 | |
Central nervous system | Sedation | 7/92 | 0/13 | 0/19 | 7/60 |
Increased dreaming | 6/92 | 0/13 | 0/19 | 6/60 | |
Fatigue | 4/92 | 0/13 | 0/19 | 4/60 | |
Headache | 1/92 | 0/13 | 0/19 | 1/60 | |
Gastrointestinal | Diarrhea | 5/92 | 1/13 | 1/19 | 3/60 |
Nausea | 4/92 | 2/13 | 0/19 | 2/60 | |
Sexual dysfunctions | Decreased libido | 12/92 | 3/13 | 3/19 | 6/60 |
Anorgasmia | 9/61 | 1/9 | 3/13 | 5/39 | |
Dry vagina | 5/61 | 0/9 | 3/13 | 2/39 | |
Ejaculatory dysfunction | 11/31 | 3/4 | 3/6 | 5/21 | |
Erectile dysfunction | 3/31 | 1/4 | 0/6 | 2/21 | |