Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
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

XGEVA

Medical condition to be studied

Osteonecrosis of jaw
Pneumonia
Skin infection
Cellulitis
Endocarditis
Encephalitis
Myelitis
Encephalomyelitis
Urinary tract infection
Pyelonephritis
Population studied

Short description of the study population

Eligibility criteria are: ≥ 18 years old, diagnosed with cancer, and, subsequent to cancer diagnosis, initiating antiresorptive treatment for SRE prevention during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from treatment for SRE prevention with oral or IV bisphosphonates of no more than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions).
The exclusion criteria are: radiation therapy to the head and neck region before a subject’s potential index date or having hypercalcemia of malignancy as the sole
indication for treatment with an anti-resorptive agent. Patients with a history of ONJ before the start of follow-up will be excluded when calculating incidence
proportions and incidence rates of ONJ.

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

Cancer patients

Estimated number of subjects

3098
Study design details

Main study objective

• Estimate, by treatment cohort, the yearly incidence proportions and 95% confidence intervals (CIs) for medically confirmed ONJ among patients with cancer whose initial antiresorptive treatment is XGEVA or IV zoledronic acid • Estimate, by treatment cohort, the yearly incidence proportions and 95% CIs for infection leading to hospitalization for XGEVA and zoledronic acid inception cohorts

Outcomes

Medically confirmed osteonecrosis of the jaw (ONJ) and infection leading to hospitalization

Data analysis plan

The 1-, 2-, 3-, 4-, and 5-year incidence proportions of medically confirmed ONJ in the three treatment cohorts were computed overall and stratified by primary cancer site, country, and calendar year of index date (2012, 2013, 2014). Patients who started follow-up in the zoledronic acid inception cohort and switched to XGEVA during the study period stopped contributing time to the zoledronic acid inception cohort and started contributing time to the XGEVA-switch cohort at the time of the switch. Binomial exact 95% CIs were computed for incidence proportions, and exact Poisson 95% CIs were computed for incidence rates.For infection leading to hospitalization, follow-up started on the cohort entry date. Only patients who had the opportunity to accrue full 1, 2, 3, 4, or 5 years after index date were included in the calculation of the respective incidence proportions. This restriction was not applied to incidence rate calculation.
Documents
Study results
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