Eli Lilly and Company

“ The study doctor and staff will send your study data to the study sponsor, its associated companies and its representatives (the "sponsor") . Because the sponsor conducts business related to clinical research in many countries around the world, this may involve sending your study data outside of Canada. If your study data is sent to other countries, your privacy will remain protected as described in this section.
Your study data will be used by the sponsor for research purposes to support the scientific objectives of the study. ”

“ In this section, "personal health information" means information about a person that relates to things like the person's physical or family health history, health care, health care provider or substitute decision-maker and that directly identifies the person, and "study data" means study-related health information that does not directly identify a person (that is, it does not contain the person's name, address, health number or other identifying information) but that does contain an assigned code number for the person and/or the person's initials. ”

“ CT scans and other x-rays are strictly controlled to make sure they use the least amount of radiation. CT scans do create low levels of radiation, which have the potential to cause cancer and other defects. But, the risk with any individual scan is small. The risk increases as the number of x-rays are done.
X-rays
You may have chest x-rays during the study. You will be exposed to a small amount of radiation during the test. The radiation that you receive from each test is about the same about what you would get in 12 days normally from all sources (natural and man-made) . ”

“ The sponsor works with business partners in drug development. The sponsor might share your study data with a business partner but only if the business partner signs a contract that requires it to protect your study data in the same way as the sponsor. ”

“ It is important that you are completely honest with the doctor and staff about your health history. You should not take part in this study if you do not meet all requirements.
You cannot participate in this study if:
You have an active infection or other serious condition such as cardiac disease You have had another malignant cancer less than five years ago You take aspirin or aspirin like medication that you are unable to stop taking for a few days during each cycle of therapy You are unable or unwilling to take folic acid, vitamin B12 and dexamethasone or other corticosteroids medication. ”

“ If you are a woman and could become pregnant, you must talk to the study doctor about birth control. You must avoid getting pregnant during the study and for 6 months after the study is completed. If you are planning to get pregnant during the study, you should not take part. ”

“ For example you might have metal in your body if you have a metal plate in your leg after a break. You may also have metal in your body if you have been exposed to metal fragments during welding. You should tell the study doctor, or MRI staff if you have any tattoos since some older tattoo ink may contain metal. Some people who do not like to be in small spaces might feel bothered by an MRI. You may also be bothered by the noise the scanner makes. ”

“ Some people complain of a warm flushing of the body. These sensations are all normal and go away within a few seconds. Rarely, some people may have a life-threatening allergic response to the contrast. ”

“ There is always a risk involved in taking a new drug but every precaution will be taken to minimize the risk
Postmarketing Data
Rare (≥ 0.01 % and < 0. 1%) cases of colitis (inflammation of the lining of the large bowel) have been reported in patients taking pemetrexed. Rare cases of radiation recall (a severe skin reaction) have been reported in patients who have previously received radiotherapy. Rare cases of interstitial pneumonitis (pneumonia involving the connective tissue of the lung) have been reported in patients treated with pemetrexed. ”

“ 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. ”