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. 2017 Oct 30;2017(10):CD006491. doi: 10.1002/14651858.CD006491.pub4

13. Mefloquine versus chloroquine; quality of adverse events reporting.

Study ID Harms predefined¹ Description of ascertainment technique² Active or passive monitoring?³ Prospective or retrospective data collection?
RCTs
Boudreau 1991 Adequate Adequate Active Prospective
Boudreau 1993 Adequate Adequate Active Prospective
Bunnag 1992 Inadequate
" Adverse events were defined clinically, and starting week 14, volunteers reporting adverse events were interviewed by members of the hospital team"
Adequate Active Prospective
Salako 1992 Inadequate
" Particular attention was paid to complaints such as fever, chills, malaise, nausea and vomiting, rashes and other symptoms and signs that could be regarded as adverse events."
Comment: no clear definition of adverse events wa s provided
Adequate Active Prospective
Sossouhounto 1995 Inadequate
" Participants had access to a village health center, where they could notify personnel of any malaise or side effects"
Unclear
" Clinical examinations and parasitologic tests were performed every 4 weeks"
Passive Prospective
Steketee 1996 Adequate Adequate Active Prospective
Cohort studies
Albright 2002 Adequate Adequate Passive Retrospective
Corominas 1997 Inadequate
Comment: insufficient information wa s provided about the questions that travellers were asked
Adequate Active Retrospective
Cunningham 2014 Inadequate
Comment: questionnaire included a targeted list of side effects, including " other psychological problems" . What was included within this was not defined
Adequate Passive Unclear
Comment: questionnaire was performed while participants were still taking chemoprophylaxis medication, although 75% were non‐compliant
Hill 2000 Inadequate
Comment: insufficient information wa s provided about the questions that travellers were asked
Adequate Active Retrospective
Korhonen 2007 Adequate Adequate Passive Unclear
Comment: No information wa s provided regarding the timing of the questionnaire during treatment
Laverone 2006 Adequate Adequate Passive Retrospective
Lobel 2001 Inadequate
"Travellers… were given a questionnaire that asked for... adverse health events attributed to those drugs"
Adequate Passive Unclear
Comment: information was collected at the airport, when travellers should still have been taking the prophylactic regimen
Napoletano 2007 Unclear
Comment: adverse events were categorised on a scale of one to four, but it is unclear whether and how causality was assessed
Adequate Active Retrospective
Petersen 2000 Inadequate
Comment: i t wa s unclear whether the questionnaire implied causality to the drug regimen
Adequate Active Retrospective
Rietz 2002 Adequate Adequate Active Retrospective
Steffen 1993 Adequate Adequate Passive Unclear
Comment: information was collected during the flight home, when travellers should still have been taking the prophylactic regimen
Stoney 2016 Inadequate
Comment: insufficient information provided on the questions that travellers were asked
Inadequate
Comment: n o information wa s reported on how adverse events were ascertained
Active Prospective
Tan 2017 Adequate Adequate Active Retrospective
Waner 1999 Inadequate
Comment: insufficient information provided on the questions that travellers were asked
Adequate Passive Unclear
Comment: information was collected during the flight home, when travellers should still have been taking the prophylactic regimen

1. Were harms pre‐defined using standardised or precise definitions?

2. Was ascertainment technique adequately described?

3. Monitoring classed as 'active' if it occurred at set time points during treatment.

For full description of analysis methods, see Table 4.