Table 3. Rate of laboratory and clinical dose limiting or Aids Clinical Trial Group grade three and four defined toxicities 30 by study arm among 812 subjects randomised to doctor or nurse monitored antiretroviral therapy in the CIPRA-SA trial in South Africa*†.
| TOXICITY | Nurse arm | Doctor arm | IRR (95% CI)** | ||
|---|---|---|---|---|---|
| Event in | Event in | ||||
| 815.74 py | Rate/100 py | 830.88 py | Rate/100 py | ||
| Laboratory: | |||||
| Haematology | 62 | 7.6 | 106 | 13 | 0.60 (0.44 - 0.82) |
| Biochemistry | 1 | 0.1 | 2 | 0.2 | 0.51 (0.05 - 5.62) |
| Liver | 44 | 5.4 | 72 | 8.7 | 0.62 (0.43 - 0.91) |
| Hyperlactataemia | 80 | 9.8 | 87 | 10 | 0.94 (0.69 - 1.27) |
| Pancreatic | 4 | 0.5 | 4 | 0.5 | 1.02 (0.25 - 4.07) |
| Renal | 3 | 0.4 | 1 | 0.1 | 3.06 (0.32 - 29.4) |
| Drug related rash | 4 | 0.5 | 5 | 0.6 | 0.81 (0.22 - 3.03) |
| Clinical HIV events: | |||||
| Tuberculosis | 28 | 3.4 | 31 | 3.7 | 0.92 (0.55 - 1.53) |
| Cervical dysplasia | 1 | 0.1 | 4 | 0.5 | 0.25 (0.03 - 2.28) |
| Neurologic | 10 | 1.2 | 32 | 3.9 | 0.32 (0.16 - 0.65) |
| Intestinal | 8 | 1.0 | 7 | 0.8 | 1.16 (0.42 - 3.21) |
| Skin | 1 | 0.1 | 2 | 0.2 | 0.51 (0.05 - 5.62) |
| Lipodystrophy, lipoatrophy | 45 | 5.5 | 51 | 6.1 | 0.90 (0.60 - 1.34) |
| Miscellaneous | 23 | 2.8 | 23 | 2.8 | 1.02 (0.57 - 1.82) |
| Clinical Non-HIV events: | |||||
| CNS | 5 | 0.6 | 13 | 1.6 | 0.39 (0.14 - 1.10) |
| Obstetric/gynaecology | 10 | 1.2 | 7 | 0.8 | 1.46 (0.55 - 3.82) |
| Miscellaneous | 34 | 4.2 | 37 | 4.5 | 0.94 (0.59 - 1.49) |
*
PHCN arm had 815.7 total person-years while the MO arm had 830.9
†
Active reporting of adverse events was undertaken by the primary care giving nurse or doctor, and a retrospective review by the study team of all laboratory adverse events greater than or equal to grade three was undertaken.
**
IRR = incidence rate ratio. CI = confidence interval