Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/7

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about what you would get in 12 days normally from all sources (natural and man-made). You may feel slightly uncomfortable as you stand for the chest x-ray.

Other Risks
In addition to the risks named above, pemetrexed, the other drugs required by the protocol, the combination of these drugs, and the study procedures might have other unknown risks.

Some methods of birth control might be less effective due to a possible interaction with pemetrexed.

It is possible that if a woman who is pregnant or breastfeeding takes pemetrexed it will harm her embryo, fetus, or breastfeeding infant.

At any time during this study, you may experience a return or worsening of your disease. It may be more likely that you will experience such return or worsening of your disease if you receive placebo in the second part of the trial (a saline solution that has a similar appearance to the study drug but has no medicine) as your study drug.

There might be unknown risks of the study drug interfering with other medications, both prescribed and over the counter. You must tell your study doctor about any medications you are currently taking. You should also consult with your study doctor before taking any new medications.

What If New Information Becomes Available?
You will be told about any important new information that is found during this study that might affect your health, well-being or willingness to stay in the study.

Will This Study Help Me?
Although the combination of pemetrexed plus cisplatin followed by pemetrexed is being tested as a possible treatment for your illness, you may not receive any health benefit from taking part in this study. You might feel better. On the other hand, it might not help you at all. It might even make you feel worse.

You might receive information about your health from any study procedures that are done during this study.

Information obtained from this study will benefit the sponsor of the study, Eli Lilly Canada Inc, and might help patients in the future.

You do not have to take part in this study to be treated for your lung cancer. There are other treatments and therapies available to you. These might include cisplatin and another chemotherapy drug. Your study doctor can discuss these treatments and therapies with you.

H3W-EW-S124 (b)
Version: 26-October-2009
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