Adverse Events of Special Interest Sample Clauses

Adverse Events of Special Interest. Adverse events of special interest represent a subset of adverse events that include autoimmune diseases and other systemic disorders of interest which could potentially have an autoimmune aetiology. Adverse events of special interest are listed below. The Principal Investigator should use clinical and scientific judgment in deciding whether other adverse events (i.e., events not listed here) could have an autoimmune origin and should therefore be reported as adverse events of special interest. • Xxxx'x Palsy • Guillain Barré Syndrome • Myocarditis • Xxxxxxx-Xxxxxxx Syndrome

Adverse Events of Special Interest. The effects of Dysport® and all BTX products may spread from the area of injection to produce symptoms consistent with BTX effects. These symptoms have been reported hours to weeks after injection. Remote spread of toxin that affects swallowing and breathing can be life threatening, and there have been reports of death. The risk of symptoms is increased in subjects who have underlying conditions (e.g. disorders of the neuromuscular junction) that would predispose them to these symptoms. Dysport® is contraindicated in individuals with known hypersensitivity to any BTX preparation or to any of the components in the formulation. Adverse events of special interest (AESIs) for Dysport® are AEs that suggest a possible remote spread of effect of the toxin or hypersensitivity. A list of preferred terms of AESIs is provided in the Statistical Analysis Plan (SAP). All AEs will be monitored by the sponsor to determine if they meet the criteria of AESIs. These AESIs will be further analysed to determine if there is a plausible possibility that they represent distant spread of toxin or hypersensitivity. In order to perform the analysis, variables including alternate aetiology (medical history, concomitant medication, or diagnosis which could account for the symptoms), location of Dysport® administration, and temporal relationship to Dysport® administration will be considered by the sponsor.

Adverse Events of Special Interest. Selected nonserious and serious AEs will be reported as AESIs. The events must be reported on the AE eCRF within 24 hours of the study site personnel’s knowledge of the event. AESIs that also meet the definition of an SAE must be reported as described in Section 10.3. Adverse events of clinical interest for this study include: • Potential major cardiac and cerebrovascular events, including death (or any event with fatal outcome), myocardial infarction, cerebrovascular accident, hospitalization for unstable angina or chest pain, hospitalization for heart failure, and coronary revascularization/angioplasty/stent • Hypertension, defined as follows: - -‌ - • AEs consistent with orthostatic hypotension as confirmed by orthostatic xxxxx xxxxx • AEs suggestive of cystitis or urinary tract infection (UTI) - - - • Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value requiring that study drug be temporarily withheld or permanently discontinued (see Sections 8.4.7.1 and 8.4.7.2). To date, no concern regarding drug-induced liver toxicity has been identified; however, the Sponsor is monitoring laboratory data for a potential safety signal, consistent with Food and Drug Administration (FDA) guidance [FDA Guidance, 2009]. Serious AESIs and elevated liver enzymes or bilirubin requiring withholding of study drug must be reported within 24 hours of the study site personnel’s knowledge of the event by marking the appropriate box on the AE eCRF and assigning the most appropriate category. Additional information should be provided as directed in the eCRF Completion Guidelines. AESIs that also meet the definition of an SAE must be reported as an SAE, as described in Section 8.4.4. Nonserious AESIs should be reported within 72 hours of the site personnel’s knowledge, using the AE eCRF.

Adverse Events of Special Interest. (AESI) Reports concerning an AESI communicated to Strakan by Aptalis (serious or non-serious regardless of source) or to Aptalis by Strakan will be exchanged by the Parties by Calendar Day 7 from Receipt Date on an FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via designated e-mail.

Adverse Events of Special Interest.  Grade ≥ 2 Congestive Heart Failure  Grade ≥ 2 QT prolongation  Any grade syncope  Grade ≥ 3 cognitive přípravku v zaměstnání, spojené či bez spojení s výskytem nežádoucí příhody, o Informace o použití produktu v pediatrické populaci nebo u seniorů pokud jsou spojené s výskytem nežádoucí příhody, o Nedostatečná účinnost spojená či bez spojení s výskytem nežádoucí příhody, o Pokud není jinak určeno v protokolu, informace o podezření na přenos infekčního agens prostřednictvím přípravku /STIAMP/. Poznámka: takové informace jsou vždy považovány za nežádoucí příhodu, o Lékové interakce, včetně interakcí lék/potravina, lék/zdravotnický prostředek a lék/alkohol. Poznámka: takové informace jsou vždy považovány za nežádoucí příhodu.  Stížnosti na produkt (spojené nebo bez spojení s výskytem nežádoucí příhody). Lékař zašle společnosti Roche všechna nezávažná ADR jednou za měsíc. Pro schválené léčivé přípravky bude Lékař sbírat všechny AE a specifické okolnosti vypsané výše (spojené nebo bez spojení s nežádoucí příhodou) a bude je předávat společnosti Roche do jednoho (1) pracovního dne od zjištění skutečnosti emailem obsahujícím všechny relevantní informace – kontakt disturbances  Any grade fractures  Cases of potential drug- induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy’s law: o Treatment- emergent ALT or AST > 3 ULN in combination with total bilirubin > 2 ULN o Treatment- emergent ALT or AST > 3 ULN in combination with clinical jaundice  Suspected transmission of an infectious agent by the study drug, as defined below: Any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non- pathogenic, is considered an infectious agent. A transmission of an infectious agent may be suspected from clinical symptoms or laboratory findings that indicate an infection in a patient exposed to a medicinal product. This term applies only when a contamination of the study drug is suspected. viz Příloha 1. Nežádoucí příhody zvláštního významu:  Kongestivní selhání srdce stupně ≥ 2  Prodloužení QT intervalu, stupně ≥ 2  Synkopa libovolného stupně  Kognitivní poruchy stupně ≥ 3  Potenciální polékové poškození jater včetně zvýšené ALT nebo AST v kombinaci se zvýšeným bilirubinem nebo klinickou žloutenkou podle kritérií Hyova pravidla: o Zvýšení ALT nebo AST v souvislosti s léčbou > 3 x ULN v kombinaci s...