A non-randomized, prospective, multicenter, observational, post-authorization study to assess the efficacy of Pelgraz® (pegfilgrastim) in the primary prevention of febrile neutropenia in patients receiving high risk myelosuppressive chemotherapy (ACCPEG1)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  PELGRAZ

Population studied

• 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:
  300

Study design details

• Main study objective:
  Primary Objective: Assessment of the effectiveness of Pelgraz® in the primary prevention of FN in patients with solid tumors, NHL and HL receiving myelosuppressive CTH with a risk of FN of 10-20% and additional individual risk factors or ≥20%. Secondary Objective: Assessment of safety and utilization pattern of Pelgraz® in patients receiving myelosuppressive CTH in the whole group and the subgroup
• Data analysis plan:
  Mean, standard deviation, median, range, quartiles (continuous data), and counts and percentages (categorical data) will be calculated for baseline demographic and cancer characteristics. All the evaluation criteria mentioned above will be estimated for each CTH cycle and presented for all the cycles separately. The overall AE incidence will be summarized in terms of patient counts and percentages over the entire follow-up period, 95% confidence intervals (CIs) will also be estimated