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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 outcomesa

HPV vaccine (N = 47,075)

Comparator (N = 48,595)

Risk ratioc [95% CI]

Cancer mortality

 Total

2

1

1.44 [0.23, 9.12]

  Cervical

1 (50%)

0 (0%)

2.99 [0.12, 73.33]

  Oropharyngeal

1 (50%)

1 (100%)

1.00 [0.10, 9.58]

Cancer incidence

 Total

7

3

1.68 [0.51, 5.49]

  Anal

0 (0%)

0 (0%)

Not applicable

  Cervical

3 (43%)

2 (67%)

1.41 [0.19, 10.21]

  Oropharyngeal

1 (14%)

1 (33%)

1.00 [0.10, 9.58]

  Penile

Not reported

Not reported

Not applicable

  Vaginal

1 (14%)

0 (0%)

2.99 [0.12, 73.33]

  Vulvar

2 (29%)

0 (0%)

3.01 [0.31, 28.89]

 Not HPV-related

20

23

0.90 [0.49, 1.63]

Carcinoma in situ incidence

 Total

367

490

0.73 [0.53, 1.00]

  Anal (AIN3)

Not reported

Not reported

Not applicable

  Cervical

367 (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 reported

Not reported

Not applicable

  Vaginal (VaIN3)

Not reported

Not reported

Not applicable

  Vulvar (VIN3)

Not reported

Not reported

Not applicable

Moderate intraepithelial neoplasia incidence

 Total

538

763

0.81 [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 reported

Not reported

Not applicable

  Vaginal (VaIN2)

Not reported

Not reported

Not applicable

  Vulvar (VIN2)

Not reported

Not reported

Not applicable

Carcinoma in situ or worse incidence

 Total

372

498

0.79 [0.59, 1.05]

  Anal (AIN3+)

Not reported

Not reported

Not applicable

  Cervical (CIN3+, AIS included)

372 (100%)

498 (100%)

0.79 [0.59, 1.05]

  Penile (PIN3+)

Not reported

Not reported

Not applicable

  Vaginal (VaIN3+)

Not reported

Not reported

Not applicable

  Vulvar (VIN3+)

Not reported

Not reported

Not applicable

Moderate intraepithelial neoplasia or worse incidence

 Total

952

1239

0.78 [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

 Total

289

582

0.56 [0.39, 0.82]

HPV-related referral proceduresb

 Any

1941

2264

0.86 [0.81, 0.90]

 Biopsy

2449

3021

0.74 [0.62, 0.88]

 Endoscopy

4354

4965

0.88 [0.85, 0.91]

 Treatment (surgical and non-surgical)

1018

1416

0.71 [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