Common use of Other Risks Clause in Contracts

Other Risks. Because the study drug is investigational, all of its side effects are not known. There may be rare and unknown side effects. These include reactions that may be life-threatening. All drugs have a potential risk of an allergic reaction. If an allergic reaction is not treated quickly, it could become life-threatening. You should get medical help right away (by calling 911 or immediately going to an emergency room) if you think you have any of the following symptoms: • Trouble breathing • Wheezing • Difficulty swallowing • Swelling of the face, mouth, lips, gums, tongue, or neck Other allergic reactions may include: • Itchiness • Rash • Hives • Blisters • Palpitations (racing heart) • Chest discomfort/tightness • Muscle pains/stiffness At times, the following may also be symptoms of an allergic reaction: • Diarrhea • Nausea • Vomiting • Abdominal pain If a significant side effect occurs, the following may be done: • Tests or treatment may be given as needed for your safety • Depending on how severe your symptoms are, you may be seen by outside medical providers or a hospital. This would be for further evaluation and/or treatment • The study investigator may notify your emergency contact as appropriate in the event of an emergency while you are taking part in the study Additional Risks or Discomforts Testing of DNA and/or RNA (deoxyribonucleic acid and/or ribonucleic acid) Genes are pieces of DNA that give coded instructions for the body. Parts of the code are passed down from parents to their children. The genes in your samples may be studied. This may include analyzing all of your genetic information. This is called “whole genome sequencing.” While collection of genetic information does not expose you to physical risk, collection of such information may result in a loss of your privacy if your genetic information is lost or stolen. There is a very small chance that your genetic information could be misused by people not involved with the research, including to discriminate against you. However, steps are in place to prevent a particular result from being linked to you and to prevent unauthorized people from even knowing genetic research was done. U.S. federal law prohibits discrimination in health insurance coverage and employment based on a person’s genetic data. However, U.S. federal law does not protect against discrimination when you are applying for: • Life insurance • Long term care insurance • Disability insurance You should talk to your physician or genetic counselor about the potential for genetic discrimination. The results of tests on your sample(s) will not be given to: • You • The study investigator • Any insurance company • Your employer • Your family • Any physician who treats you Blood Samples and IV Catheters (if used) Possible side effects of having your blood drawn or an IV catheter inserted include: • Bleeding at the site of the needle puncture • Bruising • Feeling faint • Rarely, infection or blood clot • Redness of the vein • Inflammation of the vein • Swelling • Pain • Nerve damage • Vein irritation from the fluid or medication being given • Local swelling due to IV fluid accidentally entering the tissue rather than the vein • Scarring If you feel faint, tell one of the study staff immediately.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

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Other Risks. Because the study drug is investigational, all of its side effects are not known. There may be rare and unknown side effects. These include reactions that may be life-threatening. All drugs have a potential risk of an allergic reaction. If an allergic reaction is not treated quickly, it could become life-threatening. You should get medical help right away (by calling 911 or immediately going to an emergency room) if you think you have any of the following symptoms: • Trouble breathing • Wheezing • Difficulty swallowing • Swelling of the face, mouth, lips, gums, tongue, or neck Other allergic reactions may include: • Itchiness • Rash • Hives • Blisters • Palpitations (racing heart) • Chest discomfort/tightness • Muscle pains/stiffness At times, the following may also be symptoms of an allergic reaction: • Diarrhea • Nausea • Vomiting • Abdominal pain If a significant side effect occurs, the following may be done: • Tests or treatment may be given as needed for your safety • Depending on how severe your symptoms are, you may be seen by outside medical providers or a hospital. This would be for further evaluation and/or treatment • The study investigator may notify your emergency contact as appropriate in the event of an emergency while you are taking part in the study Additional Risks or Discomforts Testing of DNA and/or RNA (deoxyribonucleic acid and/or ribonucleic acid) Genes are pieces of DNA that give coded instructions for the body. Parts of the code are passed down from parents to their children. The genes in your samples may be studied. This may include analyzing all of your genetic information. This is called “whole genome sequencing.” ”. While collection of genetic information does not expose you to physical risk, collection of such information may result in a loss of your privacy if your genetic information is lost or stolen. There is a very small chance that your genetic information could be misused by people not involved with the research, including to discriminate against you. However, steps are in place to prevent a particular result from being linked to you and to prevent unauthorized people from even knowing genetic research was done. U.S. federal law prohibits discrimination in health insurance coverage and employment based on a person’s genetic data. However, U.S. federal law does not protect against discrimination when you are applying for: • Life insurance • Long term care insurance • Disability insurance You should talk to your physician or a genetic counselor about the potential for genetic discrimination. The results of tests on your sample(s) will not be given to: • You • The study investigator • Any insurance company • Your employer • Your family • Any physician who treats you Blood Samples and IV Catheters (if used) Possible side effects of having your blood drawn or an IV catheter inserted include: • Bleeding at the site of the needle puncture • Bruising • Feeling faint • Rarely, infection or blood clot • Redness of the vein • Inflammation of the vein • Swelling • Pain • Nerve damage • Vein irritation from the fluid or medication study drug being given • Local swelling due to IV fluid accidentally entering the tissue rather than the vein • Scarring If you feel faint, tell one of the study staff immediately. ECG Possible side effects from having an ECG include: • Irritation or rash from the adhesive on the patches A rash may result in a long-lasting discoloration of your skin. If it is necessary to shave the area where the patches need to be, irritation from shaving may occur. Fasting Fasting could cause symptoms such as: • Dizziness • Headache • Stomach discomfort • Fainting • Hypoglycemia (low blood sugar) Other The length of time that you may be confined to the CRU may make you feel uncomfortable. Use of Birth Control Females You must not be pregnant or breastfeeding. You must not donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose. Females unable to have children Women in this study not able to get pregnant include women who: • Have had their uterus removed (documented) • Have had both fallopian tubes removed (documented) • Have had both ovaries removed (documented) • Have not had a period for at least 12 months in a row with no other medical cause. You may have a blood hormone level confirming that you are postmenopausal Females permanently unable to have children due to a medical cause not listed above may be allowed to participate in the study at the discretion of the study investigator.

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Samples: www.pfizerclinicaltrials.com

Other Risks. Because the study drug is investigational, all of its side effects are not known. There may be rare and unknown side effects. These include reactions that may be life-threatening. All drugs have a potential risk of an allergic reaction. If an allergic reaction is not treated quickly, it could become life-threatening. You should get medical help right away (by calling 911 or immediately going to an emergency room) if you think you have any of the following symptoms: • Trouble breathing • Wheezing • Difficulty swallowing • Swelling of the face, mouth, lips, gums, tongue, or neck Other allergic reactions may include: • Itchiness • Rash • Hives • Blisters • Palpitations (racing heart) • Chest discomfort/tightness • Muscle pains/stiffness At times, the following may also be symptoms of an allergic reaction: • Diarrhea • Nausea • Vomiting • Abdominal pain If a significant side effect occurs, the following may be done: • Tests or treatment may be given as needed for your safety • Depending on how severe your symptoms are, you may be seen by outside medical providers or a hospital. This would be hospital for further evaluation and/or treatment • The study investigator may notify your emergency contact as appropriate in the event of an emergency while you are taking part in the study Additional Risks or Discomforts Testing of DNA and/or RNA (deoxyribonucleic acid and/or ribonucleic acid) Genes are pieces of DNA that give coded instructions for the body. Parts of the code are passed down from parents to their children. The genes in your samples may be studied. This may include analyzing all of your genetic information. This is called “whole genome sequencing.” ”. While collection of genetic information does not expose you to physical risk, collection of such information may result in a loss of your privacy if your genetic information is lost or stolen. There is a very small chance that your genetic information could be misused by people not involved with the research, including to discriminate against you. However, steps are in place to prevent a particular result from being linked to you and to prevent unauthorized people from even knowing genetic research was done. U.S. federal law prohibits discrimination in health insurance coverage and employment based on a person’s genetic data. However, U.S. federal law does not protect against discrimination when you are applying for: • Life insurance • Long term care insurance • Disability insurance You should talk to your physician or genetic counselor about the potential for genetic discrimination. The results of tests on your sample(s) will not be given to: • You • The study investigator • Any insurance company • Your employer • Your family • Any physician who treats you Blood Samples and IV Catheters (if used) Possible side effects of having your blood drawn or an IV catheter inserted include: • Bleeding at the site of the needle puncture • Bruising • Feeling faint • Rarely, infection or blood clot • Redness of the vein • Inflammation of the vein • Swelling • Pain • Nerve damage • Vein irritation from the fluid or medication being given • Local swelling due to IV fluid accidentally entering the tissue rather than the vein • Scarring If you feel faint, tell one of the study staff immediately.. Tasso® Microsampling Automated Device Possible side effects of having your blood taken with the Tasso® micosampling automated device include: • Discomfort or pain at the site of the device attachment • Allergic reaction to the adhesive which could cause: o Itching o Hives o Rash o Swelling Also, the following could occur rarely: • Difficulty breathing • Coughing • Wheezing • Chest tightness with or without low blood pressure If not treated promptly, an allergic reaction can be life-threatening. Immediately tell the study investigator or study staff member if you have any of these symptoms. COVID-19 Testing Collection of a swab sample may cause: • Discomfort • Sneezing • Your eyes to water • Gagging

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

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Other Risks. Because the study drug is investigational, all of its side effects are not known. There may be rare and unknown side effects. These include reactions that may be life-threateningcause sickness or death. All drugs have a potential risk of an allergic reaction. If an allergic reaction is not treated quickly, it could become life-threatening. You should get medical help right away (by calling 911 or immediately going to an emergency room) right away if you think you have any of the following symptoms: • Trouble breathing • Wheezing • Difficulty swallowing • Swelling of the face, mouth, lips, gums, tongue, or neck Other allergic reactions may include: • Itchiness • Rash • Hives • Blisters • Palpitations (racing heart) • Chest discomfort/tightness • Muscle pains/stiffness At times, the following may also be symptoms of an allergic reaction: • Diarrhea • Nausea • Vomiting • Abdominal pain If a significant side effect occurs, the following may be done: • Tests or treatment may be given as needed for your safety • Depending on how severe your symptoms are, you may be seen by outside medical providers or a hospital. This would be for further evaluation and/or treatment • The study investigator may notify your emergency contact as appropriate in the event of an emergency while you are taking part in the study Additional Risks or Discomforts Fasting Fasting could cause symptoms such as: • Dizziness • Headache • Stomach discomfort • Fainting • Hypoglycemia (low blood sugar) Testing of DNA and/or RNA (deoxyribonucleic acid and/or ribonucleic acid) Genes are pieces of DNA that that, through material called RNA, give coded instructions for building the bodyproteins that make our bodies work. Parts These instructions are stored in the form of a code. This is the code that you inherit from your parents and that you pass on to your children. DNA, RNA, and proteins can be studied as part of genetic research. This study may involve studying your biology and whether a particular biological feature (including genes) is related to the effects or action of the code are passed down from parents study drug or to their children. The genes in your samples may be studieda disease. This may include analyzing all of your genetic information. This is called “whole genome sequencing.” While collection of genetic information does not expose you to physical risk, collection of such information may result in ”. Sequencing a loss of your privacy if your genetic information gene is lost or stolenlike reading a book 1 letter at a time. There This is a very small chance thorough way to learn about genes. The genetic analysis is for research purposes only. It is not a medical test. This means that your genetic information could the medical importance of the results may not be misused by people known. They may not involved with the research, including be related to discriminate against you. However, steps are in place to prevent a particular result from being linked to you and to prevent unauthorized people from even knowing genetic research was done. U.S. federal law prohibits discrimination in health insurance coverage and employment based on a person’s genetic data. However, U.S. federal law does not protect against discrimination when you are applying for: • Life insurance • Long term care insurance • Disability insurance You should talk to your physician or genetic counselor about the potential for genetic discriminationany medical condition. The results of tests on your sample(s) will not be given to: • You • The study investigator • Any insurance company • Your employer • Your family • Any physician who treats you Blood Samples and IV Catheters (if used) Possible side effects of having your blood drawn or an IV catheter inserted include: • Bleeding at the site of the needle puncture • Bruising • Feeling faint • Rarely, infection or blood clot • Redness of the vein • Inflammation of the vein • Swelling • Pain • Nerve damage • Vein irritation from the fluid or medication being given • Local swelling due to IV fluid accidentally entering the tissue rather than the vein • Scarring If you feel faintdo not want genetic testing to be done on your samples, tell one of you should not agree to participate in the study staff immediatelyresearch described in this document. Pfizer and researchers will put measures in place to minimize the chance that results from this research could be linked to you. There is always a chance that information from your taking part in the research may be disclosed.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

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