TABLE 5.
Most frequently reported all-causality treatment-emergent signs and symptoms (treatment related)
| All-causality AE (treatment related)a | No. of patients
|
|||
|---|---|---|---|---|
| Voriconazole group
|
Placebo group
|
|||
| Methadone alone (n = 16) | Methadone + voriconazole (n = 16) | Methadone alone (n = 7) | Methadone + placebo (n = 7) | |
| Insomnia | 1 (0) | 5 (1) | 1 (0) | 1 (0) |
| Back pain | 3 (0) | 4 (1) | 0 (0) | 1 (0) |
| Headache | 3 (0) | 2 (0) | 0 (0) | 2 (1) |
| Abdominal pain | 0 (0) | 3 (3) | 1 (0) | 2 (2) |
| Nausea | 1 (0) | 2 (1) | 0 (0) | 2 (1) |
| Somnolence | 2 (0) | 3 (1) | 0 (0) | 0 (0) |
| Constipation | 1 (1) | 2 (1) | 0 (0) | 1 (1) |
| Rhinitis | 1 (1) | 0 (0) | 2 (1) | 1 (0) |
| Abnormal visionb | 0 (0) | 3 (3) | 0 (0) | 0 (0) |
| Total no. of all-causality AEs (treatment related) | 22 (2) | 62 (23) | 8 (1) | 17 (7) |
| Total no. of patients with treatment- related AEs (%) | 2 (12.5) | 10 (62.5) | 1 (14.3) | 3 (42.9) |
a
If the same patient had more than one occurrence in the same preferred term event category, only the most severe occurrence was noted. Patients were counted only once per treatment in each row.
b
This event is known to be related to voriconazole treatment.