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Table 4 Comparison of HPV vaccine clinical study reports with trial register entries and journal publications: ratio of relative risk differences of results of benefits and harms

From: Benefits and harms of the human papillomavirus (HPV) vaccines: comparison of trial data from clinical study reports with corresponding trial register entries and journal publications

Ratios of relative risk (RRR) of results of benefits and harmsaRRR of clinical study reports vs. trial register entriesRRR of clinical study reports vs. journal publicationsRRR of trial register entries vs. journal publications
Benefits
 All-cause mortality0.95 [0.41, 2.18]1.03 [0.36, 2.92]1.08 [0.39, 3.02]
  - HPV-related cancer mortalityNot applicabledNot applicableNot applicable
 HPV-related cancer incidenceNot applicable0.55 [0.02, 17.13]Not applicable
 HPV-related carcinoma in situNot applicable0.85 [0.54, 1.36]Not applicable
 HPV-related moderate intraepithelial neoplasiaNot applicable0.98 [0.69, 1.41]Not applicable
 HPV-related moderate intraepithelial neoplasia or worseNot applicable1.02 [0.80, 1.28]Not applicable
 HPV-related treatment procedures0.79 [0.57, 1.09]0.95 [0.76, 1.19]1.20 [0.84, 1.72]
Harms
 Fatal harms0.95 [0.41, 2.18]1.03 [0.36, 2.92]1.08 [0.39, 3.02]
 Serious harms1.00 [0.90, 1.11]1.00 [0.90, 1.11]1.00 [0.93, 1.09]
  - Judged ‘definitely associated’ with CRPSb1.01 [0.63, 1.62]0.79 [0.22, 2.81]0.78 [0.22, 2.78]
  - Judged ‘definitely associated’ with POTSc0.96 [0.49, 1.88]1.07 [0.25, 4.64]1.12 [0.26, 4.86]
  - Nervous system disorders1.01 [0.60, 1.73]1.03 [0.35, 3.00]1.01 [0.35, 2.96]
 New-onset diseases0.97 [0.90, 1.05]0.99 [0.91, 1.08]1.02 [0.92, 1.09]
  - Back pain1.06 [0.73, 1.54]Not applicableNot applicable
  - Vaginal infectionNot applicableNot applicableNot applicable
  - Vascular disordersNot applicableNot applicableNot applicable
 General harms1.00 [0.92, 1.08]1.02 [0.96, 1.08]1.02 [0.94, 1.11]
  - Fatigue1.00 [0.93, 1.07]0.98 [0.88, 1.09]0.98 [0.88, 1.09]
  - Headache0.99 [0.93, 1.06]0.98 [0.91, 1.06]0.99 [0.91, 1.07]
  - Myalgia0.98 [0.79, 1.21]0.90 [0.68, 1.18]0.92 [0.68, 1.24]
  1. aRelative risk ratio differences were calculated as a risk ratio calculated with the random effects inverse variance method vs. a risk ratio calculated with the random effects inverse variance method (see Table 3)
  2. bCRPS: complex regional pain syndrome (see Table 3)
  3. cPOTS: postural orthostatic tachycardia syndrome (see Table 3)
  4. dNot applicable: when no data were available for the outcome in one (or both) of the compared study document groups (see Table 3)