| Conducting: |
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Report: |
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| Question |
Assessment |
Question |
Assessment |
| Are definitions of reported adverse effects given? |
Yes, however, there is a description overlapping about procedure and antibiotic prophylaxis adverse effects. |
Were adverse effects reported adequately? |
It is not clear. They just described adverse effects that never happened and only one that happened in the intervention group. |
| Were the methods used for monitoring adverse effects reported? Use of prospective or routine monitoring; spontaneous reporting; patient checklist, questionnaire or diary; systematic survey of |
A checklist was used to recollect data (we asked the author). |
Were any patients excluded from the adverse effects analysis? |
No, there were 6 lost to follow up patients in placebo group and 3 patients in intervention group. They did not report any adverse effect. |
| Patients? |
| • Were the methods to detect AE rigorous? |
No, they just described variables and the checklist they used. No other data to support this item. |
Does the report provide numerical data by intervention group? |
Yes, one patient had nausea (n=138) |
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Which categories of adverse effects were reported by the investigators? |
They were not described. They just described the variables. |
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Did the researchers report all important or serious adverse effects? How were these AE defined? |
Yes, they were reported but definitions were by event not by category. The events were: emesis, diarrhea, delirium, hallucinations, headache, seizures and rash. |
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Were reported the adverse effects considered for monitoring? |
Yes, all of them were reported. |
