Table 4. Number and percentage of women reporting medically significant adverse events, serious adverse events, new onset chronic diseases (NOCD) and new onset autoimmune diseases (NOAD) between 77 mo and up to 113 mo post initial vaccination (36-mo follow-up; TVC).
| Vaccine (n = 224) | Placebo (n = 213) | |||
|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | |
| Medically significant adverse events* | 60 | 26·8 (21·1 to 33·1) | 38 | 17·8 (12·9 to 23·7) |
| • Gastritis | 5 | 2·2 (0·7 to 5·1) | 2 | 0·9 (0·1 to 3·4) |
| • Incomplete spontaneous abortion | 5 | 2·2 (0·7 to 5·1) | 1 | 0·5 (0·0 to 2·6) |
| • Depression | 5 | 2·2 (0·7 to 5·1) | 1 | 0·5 (0·0 to 2·6) |
| • Hypertension | 5 | 2·2 (0·7 to 5·1) | 2 | 0·9 (0·1 to 3·4) |
| • Genital herpes | 0 | 0·0 (0·0 to 1·6) | 3 | 1·4 (0·3 to 4·1) |
| • Nephrolithiasis | 3 | 1·3 (0·3 to 3·9) | 0 | 0·0 (0·0 to 1·7) |
| • Anaemia | 1 | 0·4 (0·0 to 2·5) | 2 | 0·9 (0·1 to 3·4) |
| • Hypothyroidism | 2 | 0·9 (0·1 to 3·2) | 1 | 0·5 (0·0 to 2·6) |
| • Cervical chlamydia infection | 1 | 0·4 (0·0 to 2·5) | 2 | 0·9 (0·1 to 3·4) |
| • Bursitis | 2 | 0·9 (0·1 to 3·2) | 0 | 0·0 (0·0 to 1·7) |
| • Missed abortion | 2 | 0·9 (0·1 to 3·2) | 2 | 0·9 (0·1 to 3·4) |
| • Panic disorder | 2 | 0·9 (0·1 to 3·2) | 1 | 0·5 (0·0 to 2·6) |
| • Ovarian cyst | 2 | 0·9 (0·1 to 3·2) | 0 | 0·0 (0·0 to 1·7) |
| • Ovarian disorder | 2 | 0·9 (0·1 to 3·2) | 0 | 0·0 (0·0 to 1·7) |
| Serious adverse events* | 20 | 8·9 (5·5 to 13·5) | 11 | 5·2 (2·6 to 9·1) |
| • Incomplete spontaneous abortion | 5 | 2·2 (0·7 to 5·1) | 1 | 0·5 (0·0 to 2·6) |
| • Missed abortion | 2 | 0·9 (0·1 to 3·2) | 2 | 0·9 (0·1 to 3·4) |
| • Appendicitis | 2 | 0·9 (0·1 to 3·2) | 0 | 0·0 (0·0 to 1·7) |
| NOCD | 6 | 2·7 (1·0 to 5·7) | 3 | 1·4 (0·3 to 4·1) |
| • Hypothyroidism | 2 | 0·9 (0·1 to 3·2) | 1 | 0·5 (0·0 to 2·6) |
| • Drug hypersensitivity | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
| • Type 2 diabetes mellitus | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
| • Rheumatoid arthritis | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
| • Allergic rhinitis | 0 | 0·0 (0·0 to 1·6) | 1 | 0·5 (0·0 to 2·6) |
| • Allergic dermatitis | 0 | 0·0 (0·0 to 1·6) | 1 | 0·5 (0·0 to 2·6) |
| • Skin reaction | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
| • Vitiligo | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
| • Hypertension | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
| NOAD | 4 | 1·8 (0·5 to 4·5) | 1 | 0·5 (0·0 to 2·6) |
| • Hypothyroidism | 2 | 0·9 (0·1 to 3·2) | 1 | 0·5 (0·0 to 2·6) |
| • Rheumatoid arthritis | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
| • Vitiligo | 1 | 0·4 (0·0 to 2·5) | 0 | 0·0 (0·0 to 1·7) |
Total vaccinated cohort (TVC) included all subjects who came to the first visit and received at least one dose of vaccine or placebo; Vaccine = HPV-16/18 vaccine study group; Placebo = placebo group; n = number of subjects; n (%) = number (percentage) of subjects reporting at least one symptom; CI = confidence interval; NOCD (GlaxoSmithKline assessment) = New onset chronic disease; NOAD = New onset autoimmune disease;*listing those events with more than 1 case report in either the vaccine or placebo arm.