Risk factors For Bone Pain among Neulasta® Users (20120320)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  NEULASTA
• Medical condition to be studied:
  Bone pain

Population studied

• Short description of the study population:
  Adult patients with non-myeloid malignancies who received myelosuppresive chemotherapy regimens and were at risk of developing Febrile Neutropenia
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with non-myeloid malignancy
• Estimated number of subjects:
  1974

Study design details

• Main study objective:
  The purpose of this study is to identify risk factors for developing bone pain among Neulasta® users. Patient data from 23 pegfilgrastim clinical trials were analyzed. Multivariable logistic regression models were used to evaluate risk factors associated with moderate to severe (grade ≥ 2) bone pain and any grade bone pain in the first chemotherapy cycle and across cycles 1–6.
• Outcomes:
  The primary endpoint is the occurrence of moderate to severe bone pain (grade 2+) in cycle 1 of the study treatment chemotherapy, captured as part of Adverse Event reporting. Moderate to severe bone pain across cycles 1-6, and bone pain of any grade in cycle 1 and bone pain of any grade across cycles 1-6.
• Data analysis plan:
  Multivariable logistic regression models were used to identify risk factors associated with the occurrence of bone patin of grade ≥2 or any grade in cycle 1 and across cycles 1-6. Data collected in the trials and included in the regression model include: baseline patient characteristics (gender, region, race, age, body surface area, and baseline absolute neutrophil count), disease characteristics (primary tumor type, tumor stage), treatment characteristics (chemotherapy, radiotherapy, taxane vs no taxane treatment, and dose of pegfilgrastim), and medical history (osteoporosis/osteopenia, hypercholesteremia, anemia, neutropenia, osteomyelitis/osteonecrosis, arthritis, peripheral neuropathy, chronic fatigue syndrome, gout, bone fracture, and bone pain).

Documents

Study results

Final study report for protocol 20120320_FV_PKM _13JUL2015