Multicenter prospective open-label non-interventional uncontrolled Post-Authorisation Safety Study (PASS) to evaluate the safety profile of Polyoxidonium in daily practice

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  This PASS aims to collect data on the safety of Polyoxidonium in patients, for whom Polyoxidonium is prescribed in routine practice in accordance with the terms of the marketing authorisation (MA).
• Data collection methods:
  Primary data collection
• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This PASS is a local, multicentre, prospective, open-label, non-interventional, uncontrolled study.

Study drug and medical condition

• Name of medicine, other:
  Polyoxidonium

Population studied

• Short description of the study population:
  Adults aged 18 years or older receiveing Polyoxidonium prescription in accordance to the SmPC currently approved in Slovakia, i.e., for the treatment of any of the following diseases or conditions accompanied by secondary immunodeficiency:; - chronic recurrent bacterial infection;; - chronic recurrent viral infection;; - acute bacterial infection;; - acute viral infection;; - allergic disease (pollinosis, bronchial asthma, atopic dermatitis)
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective is: (a) to assess the frequency of adverse drug reactions(b) to estimate the proportion of subjects, who develop signs and symptoms of adverse renal effects associated with the use of Polyoxidonium.
• Outcomes:
  The primary outcome is a proportion of subjects with adverse renal effects. Proportion of subjects who experienced any AE, ADR, SAE, serious ADRs.Number of subjects who discontinued the study,Global assessment of tolerability by investigators and by subjects,Global assessment of improvement by subjects and investigators,Mean duration of primary treatment of disease,Days with fever >38°C/days with symptoms,Total and differential WBC count in blood and urine.
• Data analysis plan:
  This study focuses primarily on the safety profile of Polyoxidonium and no statistical hypothesis testing is intended. Statistical analysis will be merely descriptive in nature. Categorical data will be summarized in frequency tables. For continuous data, descriptive statistics will be calculated. For statistical comparison of categorical data, the chi-square test will be used. Parametric Student t-test or nonparametric Wilcoxon rank sum test will be used for comparison of continuous data between two independent samples. Parametric paired Student t-test or nonparametric Wilcoxon signed-rank test will be used for comparison of continuous data between two dependent samples. Proportions of two dependent samples will be compared using McNemar's test. Statistical tests will be interpreted at the 5% significance level (two-sided).Stratified analysis by indication will be performed to investigate safety profile and clinical benefit in different subjects subgroups.

Documents

Results tables

PASS report_final version 1.0 8 May 2017 SIGNED