Table 1.
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 |