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.