Table 3.
Adverse events from randomisation to week 48 assessment
| Short cycle therapy (n=99) | Continuous therapy (n=100) | Total (n=199) | ||
|---|---|---|---|---|
| Grade 3 and 4 adverse events | 13 (8) | 14 (12) | 27 (20) | |
| Clinical | ||||
| Infections and infestations | 3 | 1 | 4 | |
| Nervous system disorders* | 2 | 1 | 3 | |
| Skin and subcutaneous tissue disorders | 0 | 1 | 1 | |
| Surgical and medical procedures | 0 | 2 | 2 | |
| Kaposi's sarcoma (AIDS related) | 1 | 0 | 1 | |
| Suicidal ideation | 0 | 1 | 1 | |
| Gynaecomastia | 1 | 0 | 1 | |
| Laboratory | ||||
| Neutropenia | 2 | 6 | 8 | |
| Low density lipoprotein cholesterol increased | 1 | 1 | 2 | |
| Bilirubin increased | 1 | 0 | 1 | |
| Calcium decreased | 1 | 0 | 1 | |
| Glucose decreased | 1 | 0 | 1 | |
| Alkaline phosphatase increased | 0 | 1 | 1 | |
| ART-related adverse events (all grades) | 2 (2) | 14 (10) | 16 (12) | |
| Lipodystrophy† | 0 | 5 | 5 | |
| Gynaecomastia | 1 | 2 | 3 | |
| Suicidal ideation | 0 | 1 | 1 | |
| Dizziness | 0 | 1 | 1 | |
| Headache and syncope | 0 | 1 | 1 | |
| Spontaneous abortion | 1 | 1 | 2 | |
| Neutropenia | 0 | 1 | 1 | |
| Raised transaminases | 0 | 2 | 2 | |
| Treatment-modifying adverse events (all grades)‡ | 1 (1) | 4 (4) | 5 (5) | |
| Serious adverse events§ | 7 (6) | 6 (3) | 13 (9) | |
| Serious adverse event rate per 100 person-years (95% CI) | 6·9 (3·3–14·4) | 5·9 (2·6–13·1) | 6·4 (3·7–10·9) | |
Data are number of episodes (number of participants), unless otherwise stated. ART=antiretroviral therapy. The only significant difference in numbers of adverse events or number of patients with adverse events were in ART-related adverse events (Poisson p=0·02, Fisher's exact p=0·03, respectively).
One headache (short cycle therapy group), one hemiparesis (short cycle therapy group), and one collapse or suspected seizure (continuous therapy group).
Lipodystrophy events (continuous therapy group): two new and three worsening events with onset before baseline.
One gynaecomastia (short cycle therapy group), three worsening lipodystrophy events with onset before baseline (continuous therapy group), and one raised concentration of transaminases (continuous therapy group).
Serious adverse events in the short cycle therapy group: five admissions to hospital (one headache, one exacerbation of bronchiectasis, one Kaposi's sarcoma, one measles, and one epistaxis) and two other important medical conditions (one spontaneous abortion and one transient hemiparesis); in the continuous therapy group: one life threatening (suicidal ideation), four admissions to hospital (one contusion of chest, one collapse or suspected seizure, one spontaneous abortion, and one appendicitis) and one other important medical condition (neurosyphilis).