Known and Potential Risks and Benefits to Human Subjects Sample Clauses

Known and Potential Risks and Benefits to Human Subjects. Dysport® was first approved for the treatment of blepharospasm and hemifacial spasm in the United Kingdom in 1990. Since then Dysport® has been approved in over 80 countries for a range of indications. The posology and safety of Dysport® has been established in numerous clinical studies and there is over 20 years of postmarketing experience. Dysport® is generally well-tolerated, although temporary paralysis of nontargeted muscle groups may occur. AEs resulting from a possible remote spread of the toxin from its site of injection have been very rarely reported (including excessive muscle weakness, dysphagia, and aspiration pneumonia). Local spread of the toxin from the injection site has also been reported and therefore the safety profile is dependent on the site of injection. Most AEs are of mild or moderate severity and of limited duration. The profile of adverse reactions reported during postmarketing use reflects the pharmacology of the product and AEs seen during clinical studies. There have been occasional reports of hypersensitivity. Adverse reactions that are considered expected in patients treated across a variety of indications can be found in the current Dysport® IB and in the Dysport® Company Core Safety Information. In adult patients treated with Dysport® for NDO in the Ipsen phase IIa study [17], the reported treatment-related AEs included muscular weakness, asthenia, suprapubic pain, pain in extremity, and procedural pain. The benefits included decreased UI with a maximal effect observed as early as Week 6. These findings were consistent with improvements reported with other BTX-A formulations in phase III placebo controlled studies [8, 9]. Importantly, the decrease in UI was consistent with improvements in objective urodynamic parameters and also translated into improvements in QoL. Based on the available clinical data, the benefit/risk balance of doses of 600 U and 800 U of Dysport®, is considered to be favourable for further evaluation in this patient population (see Section 1.5). Additional information regarding potential risks and benefits may be found in the current Dysport® IB.

Known and Potential Risks and Benefits to Human Subjects. Treatment with IPP-201101 was generally safe and well tolerated when administered to both healthy subjects and patients with SLE. Injection site reactions were more frequently reported in the IPP-201101 treatment groups than in the placebo group. These injection site adverse events were mild in severity and dose related. The most frequently reported adverse events overall (those occurring in more than 2% of patients) in a Phase 2b study, in addition to injection site reaction, included urinary tract infection, nasopharyngitis, pharyngitis, influenza, bronchitis, nausea, diarrhea, and headache. However, infections such as those listed above did not appear to be more frequently reported in the IPP-201101 treatment groups compared with the placebo group. To date, the reported serious adverse events are due in part to the patients’ underlying disease. No clinically significant changes in hematology, chemistry, urinalysis, xxxxx xxxxx results, or ECG findings have been reported in the clinical program to date. No serious related unexpected adverse event reports (suspected unexpected serious adverse reactions [SUSAR] or Investigational New Drug [IND] safety reports) had been reported. Data are insufficient to determine the long-term effect of peptide-based therapy on immune competence. Additional information regarding risks and benefits to human patients may be found in the current Investigator’s Brochure.