Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/6

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failure. The longer a patient takes these drugs and the larger the dose may increase the incidence of the side effects listed above.


Folic acid

An allergic reaction including a rash, swelling or, in severe cases, difficulty in breathing has been reported in patients taking folic acid. Rarely, patients may suffer from mild stomach upsets.


Vitamin B12

Patients may experience some discomfort from the intramuscular injection. Fever, chills, hot flushes, dizziness, feeling sick, an acne-like rash and blisters have also been reported. Hypersensitivity reactions including skin reactions (e.g. rash, itching), and occasionally anaphylaxis (which may include collapse and difficulty breathing) may occur. Irregular heartbeat has been reported during early stages of treatment.


Risks and Discomforts Associated with Study Procedures
Blood Tests

You might experience some temporary discomfort when the blood sample is taken. There is a small risk of bruising, infection or swelling at the site where the needle is inserted and you might feel faint and dizzy.


Magnetic Resonance Imaging (MRI)

Generally there are no bad effects of an MRI scan. But you should not have the scan if you have any metal objects in your body. 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. You will be given ear plugs to reduce the noise of the scanner.


Computed Tomography Scan (CT Scan)

The x-rays are painless. Some people may have discomfort from lying on the hard table. Contrast (or dye) given through an IV may cause a slight burning sensation at the IV site. It can also cause a metallic taste in the mouth. 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. If you have any trouble breathing during the test, you should tell the scanner operator right away. Scanners have a 2-way speaker, so the operator can hear you at all times. 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

H3W-EW-S124 (b)
Version: 26-October-2009
Page 6 of 14
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