Table 1: Summary of selected pharmacoepidemiological studies relating to mefloquine prophylaxis safety and tolerability.

YearReference CountryPopulationStudy designNonsevere adverse event (AE) reportStandardised testing1ParticipantsSevere AE (%)2Nonsevere AE (%)2

1993[85]AustraliaMilitaryNonrandom field trialUnknownNil40n.d.n.d.

1993[78]USMilitaryRCTQuestionnaire, interviewPOMS, sleep monitoring, and ESQ2030%43%

1996[75]AustraliaCivilianRetrospectiveQuestionnaire (mail)Nil2850%6.3%

1996[80]NetherlandsMilitaryNonrandom field trialQuestionnaire (mail)Nil2,2890%22.8%

1996[83]SwitzerlandCivilianLongitudinalInvestigator nonleading questionPOMS, NES, and ESQ4200%7.9%

1997[81]UKMilitaryNonrandom field trialQuestionnaireNil3170%29.0%

1999[82]ItalyMilitaryRetrospectiveQuestionnaireNil1,3860%17.0%

2001[76]Neth., Ger., UK, Can., and SACivilianRCTQuestionnaire, interviewNil4830%3.9%

2002[77]NetherlandsCivilianRCTScreening, interviewPOMS, NES58n.d.n.d.

2005[88]AustraliaMilitaryNonrandom field trialQuestionnaireNil1,157n.d.n.d.

2005[91]CanadaMilitaryRetrospectiveData-mining medical recordsNil1,413n.d.n.d.

2007[79]JapanMilitaryNonrandom field trialQuestionnaireNil1,8760%18.2%

2008[84]SwedenMilitaryRetrospectiveQuestionnaireNil4880%57%

2010[87]AustraliaMilitaryNonrandom field trialInvestigator nonleading questionNil1620%11.7%

2014[90]DenmarkCivilianRetrospectiveAE report to drug regulatorSCL-90-R, PSE, and SF-36 (long-term)673n/a4n/a4

Total10,664

Notes.
POMS: Profile of Mood States. ESQ: Environmental Symptoms Questionnaire. NES: Neurobehavioral Evaluation System. SCL-90-R: Symptom Checklist-90-Revised. PSE: Present State Examination. SF-36: Short Form Health Survey-36.
The adverse event (AE) figures listed here are neuropsychiatric AE, where it is possible to elicit that data from the report. n.d.: not determinable.
There were 73 subjects; however 6 of these had used mefloquine at treatment doses. The remaining 67 had used the drug for chemoprophylaxis.
This was a follow-up study that only considered subjects who had submitted adverse event reports to the national drug regulator.