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

Jørgensen, Lars; Gøtzsche, Peter C.; Jefferson, Tom

doi:10.1186/s13643-020-01300-1

Systematic Reviews

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 harms^a	RRR of clinical study reports vs. trial register entries	RRR of clinical study reports vs. journal publications	RRR of trial register entries vs. journal publications
Benefits
All-cause mortality	0.95 [0.41, 2.18]	1.03 [0.36, 2.92]	1.08 [0.39, 3.02]
- HPV-related cancer mortality	Not applicable^d	Not applicable	Not applicable
HPV-related cancer incidence	Not applicable	0.55 [0.02, 17.13]	Not applicable
HPV-related carcinoma in situ	Not applicable	0.85 [0.54, 1.36]	Not applicable
HPV-related moderate intraepithelial neoplasia	Not applicable	0.98 [0.69, 1.41]	Not applicable
HPV-related moderate intraepithelial neoplasia or worse	Not applicable	1.02 [0.80, 1.28]	Not applicable
HPV-related treatment procedures	0.79 [0.57, 1.09]	0.95 [0.76, 1.19]	1.20 [0.84, 1.72]
Harms
Fatal harms	0.95 [0.41, 2.18]	1.03 [0.36, 2.92]	1.08 [0.39, 3.02]
Serious harms	1.00 [0.90, 1.11]	1.00 [0.90, 1.11]	1.00 [0.93, 1.09]
- Judged ‘definitely associated’ with CRPS^b	1.01 [0.63, 1.62]	0.79 [0.22, 2.81]	0.78 [0.22, 2.78]
- Judged ‘definitely associated’ with POTS^c	0.96 [0.49, 1.88]	1.07 [0.25, 4.64]	1.12 [0.26, 4.86]
- Nervous system disorders	1.01 [0.60, 1.73]	1.03 [0.35, 3.00]	1.01 [0.35, 2.96]
New-onset diseases	0.97 [0.90, 1.05]	0.99 [0.91, 1.08]	1.02 [0.92, 1.09]
- Back pain	1.06 [0.73, 1.54]	Not applicable	Not applicable
- Vaginal infection	Not applicable	Not applicable	Not applicable
- Vascular disorders	Not applicable	Not applicable	Not applicable
General harms	1.00 [0.92, 1.08]	1.02 [0.96, 1.08]	1.02 [0.94, 1.11]
- Fatigue	1.00 [0.93, 1.07]	0.98 [0.88, 1.09]	0.98 [0.88, 1.09]
- Headache	0.99 [0.93, 1.06]	0.98 [0.91, 1.06]	0.99 [0.91, 1.07]
- Myalgia	0.98 [0.79, 1.21]	0.90 [0.68, 1.18]	0.92 [0.68, 1.24]

^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)
^bCRPS: complex regional pain syndrome (see Table 3)
^cPOTS: postural orthostatic tachycardia syndrome (see Table 3)
^dNot applicable: when no data were available for the outcome in one (or both) of the compared study document groups (see Table 3)

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ISSN: 2046-4053

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