List of adverse reactions observed during the STICLO France and STICLO Italy clinical studies.

List of adverse reactions

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In STICLO France, 100% of the patients receiving DIACOMIT® experienced an adverse drug reaction compared to 45% in the placebo group. No serious adverse events were reported. One patient of the placebo group dropped out of the study for adverse event.

In STICLO Italy, 83% of the patients receiving DIACOMIT® experienced an adverse drug reaction compared to 27% in the placebo group. No serious adverse events were reported. One patient of the DIACOMIT® group dropped out of the study for adverse event.

Should you wish to get more information regarding DIACOMIT®’s safety during the pivotal studies, we invite you to read the product scientific discussion from the European Public Assessment Report.

For references, please access “About DIACOMIT” through the Bibliography part located in Resources tab.