Table 1B.
Summary of adverse experiences among all subjects during the entire study period
| qHPV | Placebo | Risk difference qHPV-placebo | 95% confidence interval | p value§ | |||
| (N = 2020) | (N = 2029) | ||||||
| n | (%) | n | (%) | ||||
| Subjects in analysis population | 2020 | 2029 | |||||
| Subjects with follow-up | 1945 | 1950 | |||||
| Number (%) of subjects: | |||||||
| with no adverse experience | 599 | (30.8) | 698 | (35.8) | |||
| with one or more adverse experiences | 1346 | (69.2) | 1252 | (64.2) | 4.998 | (2.03, 7.95) | 0.001 |
| injection-site adverse experiences | 1169 | (60.1) | 1047 | (53.7) | 6.411 | (3.30, 9.51) | <0.001 |
| systemic adverse experiences | 617 | (31.7) | 622 | (31.9) | −0.175 | (−3.10, 2.76) | 0.907 |
| with vaccine-related* adverse experiences | 1242 | (63.9) | 1134 | (58.2) | 5.702 | (2.63, 8.76) | <0.001 |
| injection-site adverse experiences | 1169 | (60.1) | 1046 | (53.6) | 6.462 | (3.35, 9.56) | <0.001 |
| systemic adverse experiences | 275 | (14.1) | 283 | (14.5) | −0.374 | (−2.58, 1.83) | 0.739 |
| with serious adverse experiences† | 8 | (0.4) | 11 | (0.6) | −0.153 | (−0.65, 0.32) | 0.494 |
| with serious vaccine-related adverse experiences | 0 | (0.0) | 0 | (0.0) | 0 | (−0.20, 0.20) | 1.000 |
| who died | 3 | (0.2) | 10 | (0.5) | −0.359 | (−0.81, 0.01) | 0.052 |
| discontinued‡ due to an adverse experience | 5 | (0.3) | 14 | (0.7) | −0.461 | (−0.98, −0.02) | 0.039 |
| discontinued due to a vaccine-related adverse | 2 | (0.1) | 3 | (0.2) | −0.051 | (−0.36, 0.24) | 0.657 |
| experience | |||||||
| discontinued due to a serious adverse | 3 | (0.2) | 10 | (0.5) | −0.359 | (−0.81, 0.01) | 0.052 |
| experience | |||||||
| discontinued due to a serious vaccine-related | 0 | (0.0) | 0 | (0.0) | 0 | (−0.20, 0.20) | 1.000 |
| adverse experience | |||||||
Determined by the investigator to be possibly, probably or definitely related to the vaccine.
Three subjects enrolled more than once and were excluded from this table. Serious adverse experiences in the qHPV vaccine group included appendicitis, cellulitis, non-cardiac chest pain, hypersensitivity (peanut allergy), chickenpox-related seizure, traffic accident (2-both resulted in death) and gun shot wound (resulted in death); serious adverse experiences in the placebo group included contusion related to traffic accident and the following cases of death: gun shot wound, 3; drug overdose, 2; suicide, 2; traffic accident, chemical poisoning and myocardial ischemia. Three additional subjects were considered to have serious adverse experiences as they received more than 3 doses of vaccine or placebo; none of these subjects reported adverse experiences after any of the injections they received.
Discontinued = Subject discontinued from therapy.
P-values are unadjusted for multiple comparisons.