Table 2 Laboratory toxicities during scheduled follow-up in the placebo arm by previous exposure to HBV
HBsAb negative (N=808) | HBsAb positive (N=224) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
No. of events | No. of women | % of women | Person years | Rate (per 100) person-years | No. of events | No. of women | % of women | Person years | Rate (per 100) person-years | Difference (P-value)# | |
ALT or AST | |||||||||||
Grade 1 or higher | 163 | 138 | 17.1 | 476.1 | 28.99 | 79 | 66 | 29.5 | 138.4 | 47.70 | 12.4 (0.0001) |
Grade 2 or higher | 20 | 19 | 2.4 | 527.6 | 3.60 | 4 | 4 | 1.8 | 165.0 | 2.42 | -0.6 (0.7996) |
Grade 3 or higher | 8 | 8 | 1.0 | 531.3 | 1.51 | 0 | 0 | 0.0 | 166.4 | 0.00 | -1.0 (0.2126) |
Grade 4 | 2 | 2 | 0.2 | 533.0 | 0.38 | 0 | 0 | 0.0 | 166.4 | 0.00 | -0.2 (1.0000) |
PHO G2+ and creatininemia | |||||||||||
Grade 1 or higher | 3 | 2 | 0.2 | 532.6 | 0.38 | 0 | 0 | 0.0 | 166.2 | 0.00 | -0.2 (1.0000) |
Grade 2 or higher | 0 | 0 | 0.0 | 533.3 | 0.00 | 0 | 0 | 0.0 | 166.2 | 0.00 | 0 (-) |
Grade 3 or higher | 0 | 0 | 0.0 | 533.3 | 0.00 | 0 | 0 | 0.0 | 166.2 | 0.00 | 0 (-) |
Grade 4 | 0 | 0 | 0.0 | 533.3 | 0.00 | 0 | 0 | 0.0 | 166.2 | 0.00 | 0 (-) |