跳至主要内容
临床试验/CTRI/2021/12/039065
CTRI/2021/12/039065已完成Unknown

PrescRiption Event MOnitoring for Ferric CarboxyMaltose in Management of Anemia in Indian Real Life ScEnario. (PROMISE)

Emcure Pharmaceuticals Limited1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年3月1日最近更新:

试验速览

阶段
Unknown
状态
已完成
入组人数
2,000
试验地点
1
主要终点
Adverse events occurring FCM infusion

研究概览

简要总结

Thisis a post-licensure, retrospective, prescription event monitoring,observational study. Data of patients matching the inclusion and exclusioncriteria and who received Ferric carboxymaltose (Orofer FCM) as per the locallyapproved prescribing information, will be retrieved from the medical records bythe physicians and filled in the case record forms (CRF) without revealing thepatient’s identity. Depending on the availability, data at baseline(before administering FCM) and after 4 (±) 1 weeks for each patient will befilled in the CRF in this way. The completed CRFs will be mailed to Emcure personnel for furtheranalysis and reporting as necessary. Data from the CRFs will be entered into aMicrosoft Excel Sheet and analyzed using suitable statistical method.Descriptive statistics will be calculated. Categorical data will be representedin frequencies, percentages. Quantitative data will be described as Mean ±standard deviation (SD). Data generated from this study will be compiled in a final study report. Individual results will not be reported to anyone not directly involved in this research. Research information will be published or presented in a way that does not identify the individual patient and publication of the data will be at the sole discretion of the Study Investigator.

研究设计

研究类型
Observational

入排标准

年龄范围
14.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients with iron deficiency anemia who received Ferric carboxymaltose injection (Orofer FCM) 500/1000 mg in clinical practice as per the locally approved prescribing information and treating physician is ready to share anonymized data of such patients, will be included.
  • Data for hematological parameters (hemoglobin, serum ferritin) are available at baseline and/or for minimum at 4 ± 1 weeks.

排除标准

  • Any other type of anemia apart from iron deficiency anemia.
  • Severe iron deficiency anemia with hemoglobin < 4 g/dL
  • Evidence of iron overload conditions (e.g. hemochromatosis/hemosiderosis).
  • Any malignancy.
  • Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.

结局指标

主要结局

Adverse events occurring FCM infusion

时间窗: Till 4 weeks after FCM infusion

次要结局

  • Change in hematological parameters like hemoglobin, serum ferritin, etc.(At baseline and week 4)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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