Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers

Novartis Pharmaceuticals

Overview

Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers.

Study Type

OBSERVATIONAL

Conditions

Cystic Fibrosis

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis, * moderate-to-severe lung disease, * Pseudomonas aeruginosa (PA) airway infection. Exclusion Criteria: Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Time to tobramycin solution (TIS) initiation from first year of TIS eligibility

Secondary Outcomes

Mortality

Data from ClinicalTrials.gov

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