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Table 4 Benefits and harms of the HPV vaccines: summary of HPV-related outcomes

From: Benefits and harms of the human papillomavirus (HPV) vaccines: systematic review with meta-analyses of trial data from clinical study reports

Summary of HPV-related outcomesaHPV vaccine (N = 47,075)Comparator (N = 48,595)Risk ratioc [95% CI]
Cancer mortality
 Total211.44 [0.23, 9.12]
  Cervical1 (50%)0 (0%)2.99 [0.12, 73.33]
  Oropharyngeal1 (50%)1 (100%)1.00 [0.10, 9.58]
Cancer incidence
 Total731.68 [0.51, 5.49]
  Anal0 (0%)0 (0%)Not applicable
  Cervical3 (43%)2 (67%)1.41 [0.19, 10.21]
  Oropharyngeal1 (14%)1 (33%)1.00 [0.10, 9.58]
  PenileNot reportedNot reportedNot applicable
  Vaginal1 (14%)0 (0%)2.99 [0.12, 73.33]
  Vulvar2 (29%)0 (0%)3.01 [0.31, 28.89]
 Not HPV-related20230.90 [0.49, 1.63]
Carcinoma in situ incidence
 Total3674900.73 [0.53, 1.00]
  Anal (AIN3)Not reportedNot reportedNot applicable
  Cervical367 (100%)490 (100%)0.73 [0.53, 1.00]
   Adenoid type (AIS)9 (2%)31 (6%)0.32 [0.15, 0.66]
   Squamous type (CIN3)358 (98%)459 (94%)0.85 [0.61, 1.17]
  Penile (PIN3)Not reportedNot reportedNot applicable
  Vaginal (VaIN3)Not reportedNot reportedNot applicable
  Vulvar (VIN3)Not reportedNot reportedNot applicable
Moderate intraepithelial neoplasia incidence
 Total5387630.81 [0.59, 1.11]
  Anal (AIN2)0 (0%)0 (0%)Not applicable
  Cervical (CIN2)538 (100%)763 (100%)0.81 [0.59, 1.11]
  Penile (PIN2)Not reportedNot reportedNot applicable
  Vaginal (VaIN2)Not reportedNot reportedNot applicable
  Vulvar (VIN2)Not reportedNot reportedNot applicable
Carcinoma in situ or worse incidence
 Total3724980.79 [0.59, 1.05]
  Anal (AIN3+)Not reportedNot reportedNot applicable
  Cervical (CIN3+, AIS included)372 (100%)498 (100%)0.79 [0.59, 1.05]
  Penile (PIN3+)Not reportedNot reportedNot applicable
  Vaginal (VaIN3+)Not reportedNot reportedNot applicable
  Vulvar (VIN3+)Not reportedNot reportedNot applicable
Moderate intraepithelial neoplasia or worse incidence
 Total95212390.78 [0.66, 0.91]
  Anal (AIN2+)0 (0%)0 (0%)Not applicable
  Cervical (CIN2+)892 (93%)1144 (92%)0.81 [0.68, 0.97]
  Penile (PIN2+)3 (1%)3 (1%)1.00 [0.20, 4.95]
  Vaginal (VaIN2+)17 (2%)27 (2%)0.64 [0.32, 1.27]
  Vulvar (VIN2+)18 (2%)36 (3%)0.49 [0.18, 1.36]
  Vaginal or vulvar (VIN2+ or VaIN2+)22 (2%)29 (2%)0.76 [0.44, 1.32]
External genital lesion (EGL) incidence
 Total2895820.56 [0.39, 0.82]
HPV-related referral proceduresb
 Any194122640.86 [0.81, 0.90]
 Biopsy244930210.74 [0.62, 0.88]
 Endoscopy435449650.88 [0.85, 0.91]
 Treatment (surgical and non-surgical)101814160.71 [0.63, 0.80]
  1. aSee Additional file 4 sections 1 to 8 for meta-analyses of HPV-related outcomes. It was not feasible to present this summary table for the 16 subgroups (based on age group, gender, type of HPV vaccine and comparator) of the 24 included clinical study reports
  2. bTwo trials (V501-013 and V501-015) reported ‘any’ procedure, while other trials reported individual outcomes, for example, ‘biopsy’
  3. cRisk ratios were calculated with the random-effects inverse variance method