Table 6 Adverse events since discharge reported at follow-up visit
Arm 1 KET (n = 6 that gave these data) | Arm 2 NTX (n = 5 that gave these data) | Arm 3 LA (n = 6 that gave these data) | ||||
|---|---|---|---|---|---|---|
Tolerable n (%) | Distress n (%) | Tolerable n (%) | Distress n (%) | Tolerable n (%) | Distress n (%) | |
Gastrointestinal | ||||||
Diarrhea | 1 (16.7) | 1 (16.7) | 0 (0.0) | 1 (20.0) | 1 (16.7) | 1 (16.7) |
Constipation | 2 (33.3) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Dry Mouth | 2 (33.3) | 0 (0.0) | 1 (20.0) | 1 (20.0) | 2 (33.3) | 0 (0.0) |
Nausea/vomiting | 1 (16.7) | 0 (0.0) | 1 (20.0) | 1 (20.0) | 1 (16.7) | 0 (0.0) |
Abd pain | 1 (16.7) | 0 (0.0) | 4 (80.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Incr appetite | 3 (50.0) | 0 (0.0) | 3 (60.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) |
Decr appetite | 0 (0.0) | 0 (0.0) | 4 (80.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Heart | ||||||
Palpitations | 1 (16.7) | 0 (0.0) | 1 (20.0) | 1 (20.0) | 1 (16.7) | 0 (0.0) |
Dizziness on standing | 3 (50.0) | 0 (0.0) | 2 (40.0) | 1 (20.0) | 3 (50.0) | 0 (0.0) |
Chest pain | 1 (16.7) | 0 (0.0) | 2 (40.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) |
Lungs | ||||||
Shortness of breath | 0 (0.0) | 2 (33.3) | 1 (20.0) | 2 (40.0) | 1 (16.7) | 0 (0.0) |
Cough | 1 (16.7) | 0 (0.0) | 2 (40.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Pain with breathing | 1 (16.7) | 0 (0.0) | 2 (40.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Skin | ||||||
Injection-site reaction (NTX-only) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Rash | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Increased perspiration | 1 (16.7) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) |
Itching | 0 (0.0) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) |
Dry Skin | 1 (16.7) | 1 (16.7) | 3 (60.0) | 1 (20.0) | 3 (50.0) | 0 (0.0) |
Nervous system | ||||||
Headache | 1 (16.7) | 0 (0.0) | 2 (40.0) | 1 (20.0) | 1 (16.7) | 0 (0.0) |
Tremor | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (20.0) | 2 (33.3) | 2 (33.3) |
Poor coordination | 3 (50.0) | 0 (0.0) | 2 (40.0) | 1 (20.0) | 3 (50.0) | 0 (0.0) |
Dizziness or lightheadedness | 2 (33.3) | 0 (0.0) | 3 (60.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) |
Numbness or tingling | 1 (16.7) | 0 (0.0) | 2 (40.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) |
Speech difficulty | 0 (0.0) | 0 (0.0) | 2 (40.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) |
Eyes/ears | ||||||
Blurred vision | 2 (33.3) | 0 (0.0) | 1 (20.0) | 1 (20.0) | 2 (33.3) | 2 (33.3) |
Ringing in ears | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) |
Genital/urinary | ||||||
Difficulty urinating | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) |
Painful urination | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Frequent urination | 3 (50.0) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 3 5(0.0) | 0 (0.0) |
Menstrual irregularity | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Increased libido | 2 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Decreased libido | 1 (16.7) | 1 (16.7) | 1 (20.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) |
Sleep | ||||||
Difficulty sleeping | 3 (50.0) | 1 (16.7) | 2 (40.0) | 1 (20.0) | 3 5(0.0) | 0 (0.0) |
Sleeping too much | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (20.0) | 1 (16.7) | 0 (0.0) |
Abnormal dreams | 4 (66.7) | 0 (0.0) | 3 (60.0) | 1 (20.0) | 1 (16.7) | 0 (0.0) |
Other | ||||||
Anxiety | 3 (50.0) | 2 (33.3) | 2 (40.0) | 4 (80.0) | 4 (66.7) | 1 (16.7) |
Hallucinations | 1 (16.7) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 1 (16.7) | 1 (16.7) |
Memory Loss | 2 (33.3) | 1 (16.7) | 2 (40.0) | 1 (20.0) | 0 (0.0) | 1 (16.7) |
Poor concentration | 1 (16.7) | 2 (33.3) | 3 (60.0) | 1 (20.0) | 3 (50.0) | 0 (0.0) |
Fatigue or decreased energy | 0 (0.0) | 2 (33.3) | 4 (80.0) | 1 (20.0) | 3 (50.0) | 0 (0.0) |
Restlessness | 2 (33.3) | 2 (33.3) | 4 (80.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) |
Other | 0 (0.0) | 0 (0.0) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |