Table 2

Phrases used to describe the control arm (proportion of trials)

 Phrases used ICF CSR Register Publication Synopsis Main body Protocol Abstract Full text Placebo 5/5 5/5 5/5 5/5 4/5 4/5 5/5 ‘Placebo’ or ‘matching placebo’ 5/5 5/5 5/5 5/5 4/5 4/5 5/5 ‘Placebo (which is a dose that contains no active ingredients)’ 4/5 0/5 0/5 0/5 0/5 0/5 0/5 ‘Placebo … an inactive substance’ or ‘placebo … an inactive solution’ 3/5 0/5 0/5 0/5 0/5 0/5 0/5 ‘Placebo HPV Vaccine’ 3/5 0/5 0/5 0/5 0/5 0/5 0/5 Placebo with adjuvant 0/5 1/5 5/5 4/5 0/5 0/5 5/5 ‘Placebo with adjuvant’ 0/5 0/5 2/5 0/5 0/5 0/5 0/5 ‘Aluminum adjuvant placebo’ or ‘Alum-placebo’ or ‘aluminum-placebo’ or ‘aluminum-containing placebo’ or ‘visually indistinguishable aluminum-(or ‘AAHS’)containing placebo’ or ‘matched aluminum-placebo’ or ‘placebo (aluminum adjuvant)’ 0/5 1/5 4/5 4/5 0/5 0/5 5/5 Placebo with adjuvant and dose 3/5 3/5 3/5 5/5 0/5 0/5 0/5 ‘Placebo’-containing 225 ug of aluminium adjuvant 0/5 2/5 1/5 4/5 0/5 0/5 0/5 ‘Placebo’ or ‘matched placebo’-containing Merck standard aluminium diluent (225 mcg alum), with or without mention of normal saline 0/5 1/5 0/5 2/5 0/5 0/5 0/5 ‘Placebo’-containing 225 mcg of aluminium as AAHS, with or without mention of normal saline 0/5 1/5 2/5 0/5 0/5 0/5 0/5 ‘Inactive solution (containing aluminium 225 mcg/dose)’ 3/5 0/5 0/5 0/5 0/5 0/5 0/5
• Normal saline = USP (NaCl 0.9%).

• AAHS, amorphous aluminum hydroxyphosphate sulfate; CSR, clinical study report; ICF, informed consent form.