Event | Drug group (frequency) | Placebo group (frequency) |
---|---|---|
Skin rashes | 6 | 8 |
Pruritus | 0 | 0 |
Angiooedema | 2 | 1 |
Tonsilitis | 1 | 3 |
Mortality* | 2 | 2 |
Others (convulsions*) | 3 | 0 |
Total | 14 | 14 |
*Severe adverse events as given by the DAIDS table. No statistical difference between the drug and placebo group: relative risk 3.0 (CI 0.63 to 14.27); p=0.16.
DAIDS, Division of Allergy and Infectious Diseases.