Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Elevated Liver Function Post-baseline
研究概览
简要总结
The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU) that is designed to supplement the reporting of spontaneous adverse events (AE) and better characterize known and potential safety signals for Thelin. The registry is a secure, restricted access, electronic system which collects anonymous, pre-defined, patient-level data on demographic variables, safety monitoring measurements (i.e. liver function tests, haemoglobin and international normalized ratio (INR) measurements), concomitant medications, information on AEs and Thelin drug discontinuation. Regular review of the data is conducted to assess the frequency of identified safety risks and to monitor for the emergence of new safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings, and for each Periodic Safety Update Report (PSUR).
详细描述
Non-probability sample
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a personally signed and dated informed consent document by the patient indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion.
- •Additional inclusion criteria reflect the approved label for Thelin as outlined in the SmPC.
排除标准
- •There are no specific exclusion criteria for enrollment in the Thelin Patient Safety Registry, with the exception of those reflected in the approved label for Thelin as outlined in the SmPC.
研究组 & 干预措施
Thelin Registry Patients
干预措施: Sitaxentan sodium (Drug)
结局指标
主要结局
Percentage of Participants With Elevated Liver Function Post-baseline
时间窗: Monthly up to 1 year
Elevated liver function: greater than 3 times the upper limit of normal (\>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.
Clinical Status Since Last Visit
时间窗: Monthly up to 1 year
Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.
Percentage of Participants With a Decrease in Hemoglobin Post-baseline
时间窗: Monthly up to 1 year
Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.
Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline
时间窗: Monthly up to 1 year
Total and conjugated bilirubin levels measured from blood, but indirect bilirubin calculated. Indirect bilirubin=Total bilirubin - Conjugated bilirubin. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.
Duration of Exposure to Thelin
时间窗: 1 Year
Time between the first and last dose of Thelin. For participants who continued Thelin from TOPS (another study), the initial TOPS' Thelin start date was used.
Adverse Events (AEs) by Seriousness and Relationship to Treatment
时间窗: Baseline up to year 1
Counts of participants who had AEs or treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Serious adverse events (SAEs) were reported from the time of informed consent. Relatedness to Thelin was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Concomitant Medications
时间窗: Baseline, monthly up to 1 year
Number of participants with concomitant medication usage reported by drug categories.
Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease
时间窗: Baseline up to year 1
The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.
Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results
时间窗: Baseline up to year 1
Counts of participants who had bleeding events or treatment-emergent bleeding events, defined as newly occurring or worsening after first dose. Serious bleeding events reported from time of informed consent. Relatedness to Thelin assessed by investigator (Yes/No). ERA usage: was participant taking Vitamin K antagonist? (Yes/No). INR: participant's prothrombin time (PT) ratio. Participants with multiple occurrences of an AE within a category were counted once within the category.
次要结局
未报告次要终点