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. 2014 Jul 30;2014(7):CD003488. doi: 10.1002/14651858.CD003488.pub3

Table 1.

Adverse events reported in the included studies

Study ID Number of participants Methods to monitor adverse events Blinding Comment on AE
Participants Clinicians
Min 1975 48 No comment unclear unclear No comment
Pongpanich 1973 7 No comment unclear unclear No comment
Sumarmo 1982 47 No comment blinded unclear No comment
Tassniyom 1993 32 Physical examination, blood test
No specific recording of adverse events
blinded blinded No significant difference between treatment and control groups in occurrence of fever after shock, pneumonia, convulsion, cardiac arrest, pulmonary haemorrhage, and positive hemo‐culture
No specific comments on adverse events
Kularatne 2009 100 Clinical signs recorded at baseline:
mean axillary temperature, headache, nausea, flush, pulse rate, blood pressure
Laboratory tests:
hematocrit and white blood cell count (day 0 to 4)
No specific recording of adverse events
blinded unclear No comment
Shashidhara 2013 61 No comment not blinded not blinded No comment
Tam 2012 150 Prospective adverse events reporting
active surveillance of patient‐reported symptoms and laboratory results
Laboratory tests: full blood count and random glucose level daily, with a fasting glucose test performed if the random glucose test showed a high level
Biochemistry and coagulation profiles, heparan sulfate (HS) at day 0 (enrolment) day, days 5 to 6, and at follow‐up 2 to 3 weeks after discharge
Recording: by trained study physicians using standardized structured case report form (severity, relatedness of study drugs). daily recording throughout the disease course
Reporting: regularly to the Data and Safety Monitoring Board (DSMB).
blinded blinded Transient hyperglycaemia in a small number of cases, but no significant clinical or virological adverse events detected
Villar 2009 87 Recording: systematic evaluation of adverse events during and after drug administration and monitoring
Reporting: to an independent committee to evaluate the safety and efficacy by interim analysis. These reports are available immediately, and the final report after 30 days (from protocol).
blinded blinded No adverse events reported.
Adverse events reported to the committee were defined as fatal serious adverse effects, life‐threatening or clinically significant