Table 3.
Serious adverse events reported during the long-term follow-up (LTFU) study.
| Unvaccinated control group (UCG) | HPV arm | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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| Grade3 | Grade4 | Grade 5 | Grade3 | Grade4 | Grade 5 | |||||||
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| Categories of Conditions | n=438 | % | n=1 | % | n=12 | % | n=452 | % | n=5 | % | n=4 | % |
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| Infections and infestations | 25 | 5·7% | 0 | 0·0% | 0 | 0·0% | 21 | 4·6% | 0 | 0·0% | 2 | 50·0% |
| Autoimmune disorder | 5 | 1·1% | 0 | 0·0% | 0 | 0·0% | 0 | 0·0% | 0 | 0·0% | 0 | 0·0% |
| Blood and lymphatic system disorders | 3 | 0·7% | 0 | 0·0% | 0 | 0·0% | 1 | 0·2% | 0 | 0·0% | 0 | 0·0% |
| Cardiac disorders | 2 | 0·5% | 0 | 0·0% | 1 | 8·3% | 1 | 0·2% | 0 | 0·0% | 1 | 25·0% |
| Congenital, familial and genetic disorders | 0 | 0·0% | 0 | 0·0% | 0 | 0·0% | 1 | 0·2% | 0 | 0·0% | 0 | 0·0% |
| Death of unspecified cause | 0 | 0·0% | 0 | 0·0% | 1 | 8·3% | 0 | 0·0% | 0 | 0·0% | 0 | 0·0% |
| Endocrine disorders | 4 | 0·9% | 0 | 0·0% | 0 | 0·0% | 1 | 0·2% | 0 | 0·0% | 0 | 0·0% |
| Gastrointestinal disorder | 8 | 1·8% | 0 | 0·0% | 0 | 0·0% | 11 | 2·4% | 0 | 0·0% | 0 | 0·0% |
| General disorders | 1 | 0·2% | 0 | 0·0% | 1 | 8·3% | 2 | 0·4% | 0 | 0·0% | 0 | 0·0% |
| Injury, poisoning and procedure complications | 6 | 1·4% | 1 | 100·0% | 3 | 25·0% | 9 | 2·0% | 1 | 20·0% | 1 | 25·0% |
| Metabolism and Nutrition disorders | 3 | 0·7% | 0 | 0·0% | 0 | 0·0% | 1 | 0·2% | 0 | 0·0% | 0 | 0·0% |
| Musculoskeletal and conective tissue disorders | 4 | 0·9% | 0 | 0·0% | 0 | 0·0% | 2 | 0·4% | 0 | 0·0% | 0 | 0·0% |
| Neoplasms benign, malignant and unspecified | 11 | 2·5% | 0 | 0·0% | 4 | 33·3% | 15 | 3·3% | 0 | 0·0% | 0 | 0·0% |
| Nervous system disorders | 3 | 0·7% | 0 | 0·0% | 0 | 0·0% | 5 | 1·1% | 0 | 0·0% | 0 | 0·0% |
| Pregnancy, puerperium and perinatal condition | 319 | 72·8% | 0 | 0·0% | 0 | 0·0% | 344 | 76·1% | 0 | 0·0% | 0 | 0·0% |
| Psychiatric disorders | 1 | 0·2% | 0 | 0·0% | 0 | 0·0% | 4 | 0·9% | 4 | 80·0% | 0 | 0·0% |
| Renal and urinary disorders | 4 | 0·9% | 0 | 0·0% | 1 | 8·3% | 3 | 0·7% | 0 | 0·0% | 0 | 0·0% |
| Reproductive system and breast disorders | 33 | 7·5% | 0 | 0·0% | 0 | 0·0% | 26 | 5·8% | 0 | 0·0% | 0 | 0·0% |
| Respiratory, thoracic and mediastinal disorders | 4 | 0·9% | 0 | 0·0% | 1 | 8·3% | 1 | 0·2% | 0 | 0·0% | 0 | 0·0% |
| Skin and subcutaneous tissue disorders | 2 | 0·5% | 0 | 0·0% | 0 | 0·0% | 2 | 0·4% | 0 | 0·0% | 0 | 0·0% |
| Vascular disorders | 0 | 0·0% | 0 | 0·0% | 0 | 0·0% | 2 | 0·4% | 0 | 0·0% | 0 | 0·0% |
During the LTFU only serious adverse events were reported, events grade 1 (mild) or grade 2 (moderate) represented <2% of participants then they are not presented here. Medically significant conditions were defined as grade 3 (severe), events with life-threatening consequences as grade 4 and deaths as grade 5. Data are n (%, for each column denominator)