Table 2

Safety outcomes

Cups (N=188)Pads (N=256)Controls (N=200)Total (N=644)
All severe adverse events
 Deaths recorded through HDSS0000
 Participant identified to have symptoms of toxic shock syndrome0000
 Visited health facility for toxic shock syndrome*0000
Other participant safety outcomes
 Referred for gynaecological check-up for heavy periods†5/188 (2.7%)5/256 (2.0%)0/186 (0.0%)10/644 (1.6%)
 Prevalence of Staphylococcus aureus during follow-up17/177 (9.6%)27/214 (11.2%)21/186 (11.3%)65/604 (10.8%)
 Prevalence of S. aureus at second survey of positives4/12 (25.0%)3/17 (17.6%)3/16 (18.8%)10/49 (20.4%)
 Presence of toxic shock syndrome-1 toxin in S. aureus positive samples in second survey of positives0/42/30/32/10
  • *Registries of all health facilities reviewed.

  • †Eight (four cup, four pad) of the 10 cases had recorded heavy periods at baseline.

  • HDSS, Health and Demographic Surveillance System of all homesteads.