Table 2.
Total adverse events observed in study participants reported by relationship to study drug and intensity
| Treatment group | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Tat vaccine | Placebo | Total | |||||||
| n | (m) | % | n | (m) | % | n | (m) | % | |
| Number of subjects in safety population | 100 | 100 | 200 | ||||||
| Number of subjects with at least one adverse event | 96 | (883) | 96.0 | 94 | (581) | 94.0 | 190 | (1464) | 95.0 |
| Relationship with study medication | |||||||||
| Certain | 72 | (541) | 72.0 | 59 | (250) | 59.0 | 131 | (791) | 65.5 |
| Probable | 14 | (35) | 14.0 | 23 | (38) | 23.0 | 37 | (73) | 18.5 |
| Possible | 25 | (45) | 25.0 | 28 | (56) | 28.0 | 53 | (101) | 26.5 |
| Unlikely | 41 | (80) | 41.0 | 37 | (63) | 37.0 | 78 | (143) | 39.0 |
| Not related | 76 | (182) | 76.0 | 74 | (174) | 74.0 | 150 | (356) | 75.0 |
| Not assessable | 0 | (0) | 0 | (0) | 0 | (0) | |||
| Not known | 0 | (0) | 0 | (0) | 0 | (0) | |||
| Intensity | |||||||||
| Mild | 94 | (774) | 94.0 | 91 | (522) | 91.0 | 185 | (1296) | 92.5 |
| Moderate | 42 | (90) | 42.0 | 28 | (48) | 28.0 | 70 | (138) | 35.0 |
| Severe | 15 | (17) | 15.0 | 9 | (10) | 9.0 | 24 | (27) | 12.0 |
| Not applicable | 1 | (1) | 1.0 | 0 | (0) | 1 | (1) | 0.5 | |
| Not known | 1 | (1) | 1.0 | 1 | (1) | 1.0 | 2 | (2) | 1.0 |
| Serious adverse events | 6 | (8) | 6.0 | 2 | (2) | 2.0 | 8 | (10) | 4.0 |
| Related | 0 | (0) | 0.0 | 0 | (0) | 0.0 | 0 | (0) | 0.0 |
| Not related | 6 | (8) | 6.0 | 2 | (2) | 2.0 | 8 | (10) | 4.0 |
n = number of subjects, (m) = number of mentions, % = all percentages are expressed as the percentage of the number of subjects in the safety population in each treatment group