Gemzar® (gemcitabine hydrochloride)

Consistent with the company's policy of public data disclosure, this clinical trial results section includes result summaries of completed Lilly-sponsored clinical studies conducted on Lilly marketed products since July 1, 2004. The results of all Phase I, II, and III trials conducted in support of a product’s initial registration will be disclosed regardless of outcome, no later than when the first indication is approved and the drug is commercially available for patient use anywhere in the world. The results of all subsequent Phase II, III, and IV trials conducted after initial approval will be similarly disclosed within one year of trial completion. A trial’s results, irrespective of study phase, will be disclosed as soon as possible if there are significant safety findings.

Consistent with ICH E3 guidelines, Lilly will disclose the results of primary and secondary outcome measures that are specified in the study protocol, as well as additional safety and efficacy results that impact patient care and the use of our products. Also, Lilly discloses a comprehensive description of the trial design and methodology for each study. Results will be disclosed regardless of whether they support the hypothesis being tested or are contrary to the predicted outcome. Clinical trial results will be publicly disclosed as stated above, unless posting would compromise publication in a peer reviewed medical journal or contravene national laws or regulations. Results of studies that are under review by peer-reviewed journals that prohibit pre-publication disclosure will be posted on the registry at the time of publication. Clinical trial results are also disclosed through presentations and abstract submissions at professional scientific meetings.

The registry is also populated with the results of core efficacy and safety registration trials for products first approved after July 1, 1994.

Included are trial result summaries that are completed to date. The company will continue to disclose additional summaries and publication citations as they become available.

Summaries of clinical study results are intended to report the results of the study that were known at the time of each study's completion. The information contained in these summaries is not intended to promote or otherwise commercialize (directly or indirectly) any off-label or unapproved uses of Lilly medicines, nor is it intended to provide a comprehensive analysis of all data currently available regarding a particular drug. In some cases, more current information regarding a drug, including post-hoc analyses and meta-analyses, may be available as part of the general body of scientific knowledge in forms such as manuscripts, abstracts, or posters.

Clinical studies on Lilly products may also be sponsored and reported by parties other than Lilly in other clinical trial registries.

Trial Results

The following trials have been conducted for Gemzar.