your best interest to stop taking the drug. Afterwards, your doctor will ask you to visit him on regular basis to follow-up on your health status.
After the study ends, you may be given the choice to continue to receive pemetrexed. This will happen only if the study doctor and study sponsor believe the drug may be of benefit to you. Pemetrexed may be provided by the study sponsor until your disease worsens OR until pemetrexed is approved for sale in Canada if the study doctor continues to believe it is benefiting you and the study sponsor continues development of pemetrexed.
Study Procedures
Blood samples will be taken at different time points as described in Attachment 1. The purpose of these blood samples is to help your study doctor decide if you can take part in this study and to check your health during the study. The blood samples will be tested to make sure the levels of certain things in your blood are normal (e.g. Liver Function Tests, to make sure your liver is working right). About 2 to 3 teaspoonfuls (up to 15 milliliters) of your blood will be taken each time. A blood sample will also be taken at the beginning of the study if you are a female to see whether you are pregnant or not.
All Blood samples collected for specified laboratory tests will be destroyed within 60 days of confirmation of the test results, unless laws, regulations, or international laboratory certification standards require a longer retention period. This confirmation will either occur immediately after initial testing, or may require that samples be held to be retested at a defined later point in time.
At every other visit (Visit 2, 4, and so on), or when needed, radiological exams will be completed to take a series of pictures of your body. These will include CT scans, Magnetic Resonance Imaging (MRIs) or chest X-rays, as applicable.
Following your active participation in the study, the study doctor or one of the staff members may contact you to obtain information regarding the status of your health and quality of life. If you have moved or plan to move, please provide your new contact information to the study doctor or his staff.
What Are The Possible Harms and Side Effects?
If you take part in this study, there may be risks to you.
As of 13 March 2008, approximately 15,925 patients had been enrolled in clinical studies around the world to receive pemetrexed (ALIMTA®, LY231514).
Risks and Discomforts Associated with Pemetrexed
Very common (≥10%)
Very common side effects reported by those taking pemetrexed include a decrease in white blood cells and red blood cells, and short-lived increases in some tests that show how the liver is working. A decrease in white blood cells increases the chance of developing an infection, with or without fever. A decrease in red blood cells (anemia) may cause loss of
Version: 26-October-2009
