An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Rate of Primary Lung Cancer Mortality

Outcome Description:

Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.

Outcome Time Frame:

Baseline from original trial up to Year 2 of this study

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Institutional Review Board

Study ID:

A2171121

NCT ID:

NCT00734591

Start Date:

August 2008

Completion Date:

January 2012

Related Keywords:

• Diabetes Mellitus
• Observational Study Exubera
• Diabetes Mellitus