TABLE 3.
Incidence of adverse events from the intent-to-treat analysis set
| AE(s)a |
n (%) with RPV at 25 mg q.d. |
||
|---|---|---|---|
| 1st 48 wk (n = 36) | wk 48–240 (n = 24) | Overall treatment phase (n = 36) | |
| Patients with ≥1 AE | 34 (99.4) | 22 (91.7) | 35 (97.2) |
| AEs occurring in >10% of patients | |||
| Upper respiratory tract infection | 8 (22.2) | 15 (62.5) | 20 (55.6) |
| Blood cortisol decrease | 7 (19.4) | 0 | 7 (19.4) |
| wt decrease | 4 (11.1) | 0 | 4 (11.1) |
| Headache | 5 (13.9) | 5 (20.8) | 9 (25.0) |
| Somnolence | 5 (13.9) | 0 | 5 (13.9) |
| Bronchitis | 4 (11.1) | 0 | 4 (11.1) |
| Influenza | 13 (36.1) | 4 (16.7) | 15 (41.7) |
| Urinary tract infection | 2 (5.6) | 3 (12.5) | 4 (11.1) |
| Dental caries | 2 (5.6) | 3 (12.5) | 3 (8.3) |
| Cough | 8 (22.2) | 3 (12.5) | 10 (27.8) |
| Nausea | 4 (11.1) | 1 (4.2) | 5 (13.9) |
| Depression | 7 (19.4) | 2 (8.3) | 8 (22.2) |
| Patients with ≥1 SAE | 6 (16.7) | 0 | 6 (16.7) |
| AEs leading to study discontinuations | 1 (2.8) | 0 | 1 (2.8) |
| AEs leading to deaths | 0 | 0 | 0 |
| Patients with ≥1 AE related to RPV | 13 (36.1) | 1 (4.2) | 13 (36.1) |
| AEs with ≥1 DAIDS grade 3/4 | 5 (13.9) | 2 (8.3) | 7 (19.4) |
| Depression | 1 (2.8) | 1 (4.2) | 2 (5.6) |
| Neutropenia | 0 | 1 (4.2) | 1 (2.8) |
| Pancreatitis | 1 (2.8) | 0 | 1 (2.8) |
| Blood phosphorus decreased | 1 (2.8) | 0 | 1 (2.8) |
| Malaria | 2 (5.6) | 0 | 2 (5.6) |
| Abscess limb | 1 (2.8) | 0 | 1 (2.8) |
| Suicidal ideation | 1 (2.8) | 0 | 1 (2.8) |
| Suicide attempt | 1 (2.8) | 0 | 1 (2.8) |
| AEs of special interest | 24 (66.7) | 8 (33.3) | 26 (72.2) |
| AEs of special interest in >10% of patients | |||
| Headache | 5 (13.9) | 5 (20.8) | 9 (25.0) |
| Somnolence | 5 (13.9) | 0 | 5 (13.9) |
| Dizziness | 3 (8.3) | 2 (8.3) | 4 (11.1) |
| Depression | 7 (19.4) | 2 (8.3) | 8 (22.2) |
| Blood cortisol decreased | 7 (19.4) | 0 | 7 (19.4) |
| Rash | 4 (11.1) | 0 | 4 (11.1) |
a
AE, adverse event; DAIDS, Division of AIDS; q.d., once-daily; RPV, rilpivirine; SAE, serious adverse event.