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To be presented on local headed paper RAMPART Clinical TrialWe are inviting you to take part in a research study called RAMPART Please take time to read the following information carefully. Discuss it with friends and relatives if you wish. You are free to decide whether or not to take part in this research study. If you choose not to take part, this will not affect the care you get from your own doctors in any way. Take time to decide whether or not you wish to take part.You may not benefit directly by participating in this study but by taking part and attending follow-up visits you will help us find out if the treatments may benefit kidney cancer patients like you in the future. You can stop taking part in the study at any time, without giving a reason.Ask us if there is anything that is not clear or if you would like more information. Thank you for reading this information. If you decide to take part you will be given a copy of this information sheet and asked to sign a consent form. You will get a copy of the signed form to keep also. Important things to knowThe study is being run by a study team at the Medical Research Council Clinical Trials Unit which is based at University College London (UCL), the MRC CTU at UCL. Throughout this information sheet we will refer to the MRC CTU at UCL (where this study is run from) or UCL (the organisation that is legally responsible for the study). You can find more information about the organisation of the study on the study website rampart-.Immunotherapy is a type of cancer treatment that ‘wakes up’ a patient’s own immune system so it can fight cancer.We are testing two new immunotherapy drugs to determine whether taking one or both may stop or delay your cancer coming back. If you take part you will be allocated at random to one of 3 different groups by a computer program. Neither you nor your doctor will decide which group you will be in. You may receive no study treatment (the current standard-of-care), one drug or two drugs. Like all medicines, the drugs used in this study can have unwanted sideeffects. It is important for you to read the section where these side-effects are described.If you take part in this study, we will ask that you attend regular appointments at the hospital to receive your treatment and to be monitored closely for side-effects. These appointments may take up to half a day depending on the group to which you are allocated. We will also ask you to attend further hospital visits after your treatment has finished so that we can find out how you are.ContentsWhy are we doing this study?Why am I being asked to take part? What do I need to know about the medicines used in this study?What will I need to do if I take part?What are the possible sideeffects?What are the possible benefits of taking part? What are the possible disadvantages and risks of taking part?What biological samples will be collected as part of this studyWhat other sub-studies could I take part in?More information about taking partContacts for further information How to contact usIf you have any questions about this study, please talk to your doctor or nurse:Name of doctor or nurseHospital DepartmentHospitalStreetCity/TownPostcodeTel: XXXX XXX XXXX1Why are we doing this study?How is research done?The best way of knowing whether one treatment is better than another is by carrying out a ‘randomised controlled trial’. A randomised controlled trial compares two or more groups of people: one or more research groups receive the new ‘research’ treatment(s) and a control group receive the existing ‘standard’ treatment. This allows researchers to see whether a new treatment is better than an existing treatment. In this information sheet we call this randomised controlled trial a ‘study’.What is kidney cancer?Cancer starts when cells in the body begin to grow out of control. Cells in nearly any part of the body can become cancer, and can spread to other areas of the body. Kidney cancer is a cancer that starts in the kidneys. It is still called kidney cancer even if it spreads to other parts of the body.If you want to know more about kidney cancer, you can talk to the doctor or nurse who is treating you. You can also find some useful information at the end of this information sheet. How is kidney cancer usually treated?Removing the kidney (or part of a kidney) by surgery is currently the best treatment if you have kidney cancer like yours. The current standard treatment after surgery is ‘active monitoring’. This means no further treatment, but having regular checks so that if the cancer does come back further treatment options can be considered as early as possible. What are we trying to find out?We are aiming to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) can prevent or delay kidney cancer coming back. 2Why am I being invited to take part?You are being told about the RAMPART study and invited to take part because you have recently had surgery to remove your kidney cancer. The doctors treating you believe that there is a risk that the cancer may return. 3What do I need to know about the drugs in this study?What is Durvalumab?Durvalumab is a type of treatment called an immunotherapy, and may sometimes be referred to as an ‘anti-PDL1 drug’ or ‘immune checkpoint inhibitor’. It works by helping your own immune system to attack the cancer. Durvalumab is currently being tested by itself or in combination with other treatments in many types of cancer. Early studies have shown that durvalumab works well and has side effects that can usually be controlled. A similar drug, nivolumab, has been shown to be effective in treating a number of different types of cancer (lung cancer, a type of skin cancer called melanoma and kidney cancer that has spread outside the kidneys). For these reasons, we think durvalumab is a worthwhile drug to test for patients like you to see if it will prevent or delay your kidney cancer returning.What is Tremelimumab?Tremelimumab is another immunotherapy treatment for cancer. It may sometimes be called an ‘anti-CTLA4 drug’ or ‘immune checkpoint inhibitor’. It also works by helping your immune system to attack the cancer. It has been shown to be effective in treating a number of different types of cancer, particularly when used in combination with other cancer treatments. A similar drug called ipilimumab has been shown to be effective in combination with nivolumab (the drug that is similar to durvalumab) for treating patients with melanoma (a type of skin cancer) that has spread to their organs. The combination is also being tested in kidney cancer that has spread outside the kidney.4What will I need to do if I take part? Can I definitely take part?Not everyone may be able to take part in this study. We need to do some tests first to see whether you are suitable to take part.You will need to have a CT scan to see if any cancer is still present in your body. If cancer is present you won’t be able to enter the study, but there are other treatment options your doctor will discuss with you.We will ask that you provide blood and urine samples for testing, and you will have an electrocardiogram (ECG). An ECG is a simple, painless test that records the heart's electrical activity. These tests are to make sure that it will be safe for you to take the study drugs.You will also need to join the study within 3 months (91 days) of having surgery to remove your kidney cancer. What if the tests show I can take part?If tests show you are fit to take part and you agree to join the RAMPART study, you will be randomly assigned to one of 3 different groups. These are also known as Groups A, B and C and are shown in the diagram here:Everyone who takes part will be in one of these groups. Which group will I be in? Because we do not know if the new treatments will be better than the current standard of care (no treatment), it is important that the patients in each group are as similar as possible at the start of the study. As we mentioned earlier, a process called randomisation is used to allocate people to each group. We use a computer program to do this. Your doctor will not have any say in which group you are allocated. For every 7 patients entered into the study, 3 will be allocated to Group A, 2 to Group B and 2 to Group C.What will happen to me during the first year on study? If you are allocated to group A:You will not receive any study drugs. During your first year on study you will be asked to attend appointments at your hospital for regular CT scans (see section below entitled ‘What tests and checks will be done’ for more information). Your appointments will take place every 4 months from the day you join the study up to the end of the first year. In total you are expected to have 3 study visits during the first year. If you are allocated to group B:You will be given a dose of durvalumab every 4 weeks for up to one year. During your first year on study you will be asked to attend an appointment at your hospital every 2 weeks during the first eight weeks and then every four weeks for the rest of the year so that your doctor can see how you are doing and so you can have regular blood tests. In total you are expected to have 13 study visits during the first year. If you are allocated to group C:You will be given a dose of durvalumab every 4 weeks for up to one year. You will also receive a dose of tremelimumab at the first two treatment visits (day 1 and week 4). During your first year on study you will be asked to attend an appointment at your hospital every 2 weeks during the first eight weeks and then every four weeks for the rest of the year so that your doctor can see how you are doing and so you can have regular blood tests.You will be seen one month after completing your treatment and two months after that just to make sure all blood results look normal and to check how you are doing. In total you are expected to have 13 study visits during the first year. What will happen to me after completing the first year on study?After the first year on study, all patient groups (A, B and C) will be followed-up in line with the current standard-of-care for patients with kidney cancer. You will be seen after 3 months to make sure all blood results look normal and to check how you are doing. Your doctor will then want to see you for a check-up every 3 months up to the end of year 3, then every 6 months up to year 5 and annually thereafter. Sometimes your doctor may need to see you more frequently. You will continue to have CT scans to check that you kidney cancer has not returned but these will become less frequent over time. This means that all patients are expected to have 17 study visits in total after completing the first year.For further details please see the visit plan in Table 1.How are the drugs given? Both drugs (durvalumab and tremelimumab) are given as infusions. Your nurse will need to put a small tube into a vein in your hand or arm. The drugs are then given directly into the vein. Each infusion will take roughly 1 hour. You will be monitored in hospital during and after the infusion to ensure there are no problems with your treatment.What checks and tests will be done?You will have blood tests for the duration of the study. Some of these tests are additional to those you would normally have as part of routine care but they will be done to coincide with your treatment schedule or hospital visits. As part of routine care you would normally have 10 blood tests. If you choose to participate in the study you will be expected to have up to 12 blood tests if you are in group A and up to 24 blood tests if you are in group B orC. You will also have regular CT scans to check that your kidney cancer has not returned. These are the same type and frequency of scans you would receive if you did not agree to participate in the study, except that there may be an extra one or two in the first year compared to what is standard in some hospitals. In total you are expected to have 12 CT scans as part of the study. During your first year on the study you will have a CT scan every 4 months. The CT scans will continue every 6 months up to year 3, and will then be done at years 4, 5, 7 and 10. Please see the visit plan at the end of this information sheet (Table 1) for full details of the procedures required at each visit.What if I change my mind about taking part? You can stop taking part in all of this study, or in any part of it, at any time and without giving a reason, but we would ask that you talk to your study doctor or nurse first. They may be able to advise you about any concerns you may have. In order to find out if the treatments work as we hope we need to obtain long-term follow up on as many patients as possible. For this reason, we would like to continue gathering information about your health status even if you decide to stop treatment. We can do this in a variety of ways including: collecting information during your clinic visits or from your clinical notes, your doctor or nurse contacting you by telephone or contacting your GP. Your doctor or nurse will talk you through possible options for continuing your follow-up in the most convenient way for you.If you stop taking part in this study, your doctor will discuss options for further treatment with you (which may be active monitoring). A decision to stop taking part at any time will not affect the standard of care you receive.What if my cancer comes back? If a CT scan shows that your cancer has come back you will need to stop any treatment you are receiving as part of the study. You and your doctor will discuss options for further treatment with you. 5What are the possible sideeffects?All drugs can have unwanted sideeffects. There are a number of known side-effects for both durvalumab and tremelimumab and these are summarised in Table 2.Among the most common and serious side effects, it is important you are aware that either treatment can cause: fever, fatigue, rash, itchiness, bleeding from nose or gums, difficulty breathing, nausea, vomiting, swelling, bloating, liver functions disorders, inflammation of the pancreas, diarrhea, yellowing of the skin and whites of the eyes, headaches, myocarditis (inflammation of the heart muscle), increased heart rate, dizziness, loss of or decreased appetite, joint pain, cough, dehydration and thyroid disorders (constipation, dry skin, weight gain, muscle weakness, hand tremors, mood swings, anxiety, heart palpitations, trouble sleeping). Durvalumab and tremelimumab are still fairly new treatments and so there may be other sideeffects which we do not know about yet. Please tell your doctor or research nurse if you experience any symptoms, no matter how big or small. Occasionally side-effects may be severe and in some cases may result in hospitalisation. If you become concerned about any side effects between hospital visits, please seek advice immediately from your nurse or doctor; contact details for your local team can be found in Section 11 of this information sheet). Please let your research team know if you attend your GP or hospital for any new problems.The treatments being tested in this study may include unknown risks to an unborn child; therefore pregnant or breast-feeding women will not be allowed to participate in this study. A pregnancy test will be performed on all women of childbearing potential at the start of the study and prior to each infusion. Female participants of childbearing potential who are sexually active with a male partner who has not been sterilized (vasectomy) will need to use one of the methods of contraception listed in Table 3. This also applies to a female partner of a male participant. Male participants who have not been sterilized (vasectomy) and who are sexually active with a female partner of childbearing potential must also use a male condom plus spermicide. This will also apply to a male partner of a female participant. Both men and women participating in the study need to be using one of the contraception methods listed in Table 3 for the entire duration of their treatment and up to 6 months after completing it. If you are unsure about an appropriate method of contraception, please speak to your doctor or nurse. Please make sure you speak to your partner about these contraception methods so they are also aware of what is required by this study.Egg or sperm donation is not allowed and breastfeeding must be avoided. It is important you let your doctor or nurse know if you or your partner become pregnant during the course of the study as it is key this is followed up by the study team at the MRC CTU at UCL.6What are the possible benefits of taking part in this study?We do not know whether you will gain any benefit personally from taking part in this study. However, the information we get from this study will improve our knowledge of treatment for future patients with kidney cancer and potentially change the future standard-of-care for patients like you.7What are the possible disadvantages and risks of taking part? You might experience side-effects from the treatment that you take in this study. Side-effects of durvalumab and tremelimumab are listed in Section 5. You can also see the full list of known side-effects in Table 2 of the study protocol which you can access via the study’s website (rampart-).Drawing of blood may cause pain or bruising. It is also possible that skin or vein irritation, blood-clot formation, bleeding, bleeding from the injection site, or infection could occur.There is a small chance you might have a reaction from the dye used for your routine CT scans; this risk is small and you will be monitored by the clinical team throughout your CT scan. CT scans use x-rays which are a type of ionising radiation. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. The chances of this happening to you as a consequence of routine CT scanning over 120 months is about 2%. Taking part in this study will marginally increase these chances from 2% to 2.1%.You will be asked to attend some extra appointments during year 1 of the study. However, after year 1 the number of follow-up appointments will be the same as if you were not in the study.If you have private medical insurance or require travel insurance, your policy may be affected. You should check this with your insurance provider.Patients and their partners will need to use appropriate contraception listed in Section 5.8What biological samples will be collected as part of this study?It is becoming more and more important to understand how a person’s genetic make up influences their cancer, how they respond to treatment, and why certain side effects are experienced more severely by some people than others. Everyone taking part in RAMPART will already have had surgery to remove part or all of their kidney. In order to take part in the study we ask that all patients allow us to collect some of the tissue that was already removed during surgery. We also ask that patients agree to provide a blood sample before their first infusion. This small blood sample (less than a teaspoon full) will be taken while other blood samples are being done as part of the study or routine clinical care so there won’t be a need to pierce your skin specifically for this.Your research team will send this blood sample to a central laboratory for future analysis. This part of the study is mandatory, i.e. both the tumour and the blood sample must be provided. What will happen to these samples?The collection of any biological samples as part of the study will require collaboration with other institutions outside the MRC CTU at UCL. Your samples will be sent to a central lab at Cambridge University where they will be stored for at least the duration of the study. The samples may be tested to help understand factors that may cause kidney cancer or affect the way the cancer responds to immunotherapy treatments.The samples (or data generated from them) may be shared with other universities, NHS hospitals or commercial collaborators, possibly from outside the EEA and who might be using specialised testing methods. Proposals for the use of the samples collected in this study will be assessed on a case-by-case basis by an independent trial oversight committee.Your samples will always be anonymous and the researchers will not be able to trace any of the samples collected back to you. All samples collected will be put together with samples from hundreds or thousands of other people and might be used to develop new treatments or tests in the very long-term. The sample is a gift and we would not expect to share in any profits arising from that research. All data will be analysed for all participants and no individual results will be communicated back to participants.9What other sub-studies could I take part in?We want to know how well people in the trial are feeling and doing. We also want to know how much good they think durvalumab or a combination of durvalumab and tremelimumab needs to do for it to be worthwhile. You may therefore be asked to participate in two sub-studies that involve the completion of questionnaires. The Quality of Life and Health Economics sub-study requires you to complete two very short questionnaires before you start treatment and at 3 of your clinic visits (week 16, month 15 and month 36). You will also be asked to complete the questionnaires if your cancer comes back. Each questionnaire should take less than 5 minutes to complete.The Patient Reported Outcomes sub-study requires you to complete a questionnaire before you start treatment and at 3 of your clinic visits (week 16, month 15 and month 36). This questionnaire should take less than 20 minutes to complete.These sub-studies are both optional and you will be asked during consent whether you wish to take part.10More information about taking partDo I have to take part in the RAMPART study?No, your participation in the RAMPART study is entirely voluntary. It is up to you to decide whether or not to take part. If you decide to take part you will be given this participant information sheet to keep and you will be asked to sign a consent form.If you decide not to take part in this study, you will receive the standard treatment, which is active monitoring (the same as Group A). A decision to not take part at any time will not affect the standard of care you receive.Will I get back any travel costs?There will be no payments to patients who decide they want to take part in this study and additional travel expenses cannot be reimbursed.What will happen to information about me collected during the study? If you agree to take part in this study, your doctor will send information about you, your kidney cancer and your progress during the study to the MRC CTU at UCL. The information will be stored on a secure database. Fully anonymised copies of the CT scans taken while you take part in the study will be collected and securely stored We do this in case we need to verify the results of your CT scans that your doctor will provide us with. Scans will be stored using a Microsoft product called Azure which has been set up to ensure your data is protected and safeguarded. No sensitive or personal information will be kept with your scans.At various times during the study your hospital notes may be looked at by the study team and other responsible persons to confirm that the study has been carried out appropriately.When follow-up for all the patients in the study is complete, the collected information will be analysed by the study team. Information held, for example by the NHS, may be used to provide information about your survival and disease status during and after your participation in the study might have terminated. This information may be provided by a variety of national registries and bodies such as the Office of National Statistics (ONS) , NHS Digital or other institutions that might be formed in the future for this purpose. There is a question about this on the consent form that we will ask you to sign before you begin the study. We would keep this information separate from other information we collect about you. All data will be kept securely and confidentially, with identifiable data such as your name, NHS number or postcode held separately from clinical data. The information we collect about you may also be useful in future research. Other researchers, including some who may be working outside the EEA, may ask to use your information. If they do, this will be considered very carefully by RAMPART researchers, the MRC CTU at UCL and independent scientists. If your data is shared with other researchers, it will be anonymised to ensure that your identity is protected. We will follow all legal requirements to make sure that all information about you is treated appropriately and ethically, and that other researchers do so too. Your data will be stored by the MRC CTU at UCL for 25 years after the completion of the study. This is in line with UK law.Who is organising and funding the study? This study is organised by the MRC CTU at UCL, which has run high quality cancer studies for many years. The study coordination, data collection and analysis and administration will be provided by the MRC CTU at UCL. You can find out more about us at ctu.mrc.ac.uk.The MRC CTU at UCL has overall responsibility for the conduct of the study. We are responsible for ensuring the study is carried out ethically and in the best interests of the study participants. Patient representatives have been involved in the design and management of this study and also in writing this information.The study is funded by Kidney Cancer UK, University College London and by an educational grant from Astra Zeneca, the manufacturer of durvalumab and tremelimumab.Your doctor is not receiving any money or other payment for asking you to be part of the study. A payment will be made to the hospital to cover any additional costs associated with treating and looking after patients who take part in the study.Who has reviewed the RAMPART study?The study has been reviewed by international scientists. It has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA), as well as by London Riverside Research Ethics Committeeand your hospital’s Research and Development Office. The IRAS Project ID (219487) is a single reference for all of the reviews which have been conducted.What if new information becomes available during the course of the study?Sometimes during a study, new information becomes available about the drugs that are being studied. If the information is relevant to your taking part in the study, your doctor will explain the new information to you and discuss whether you want to continue on the study. The study will be monitored regularly by independent, expert groups to make sure there is a balance between the potential benefit of the treatments and their side effects compared to active monitoring. If you decide to stop taking part in the study, your doctor will arrange for your care to continue outside of the study.Your doctor might also suggest for other reasons that it is in your best interests to stop taking part in the study. Your doctor will explain the reasons and arrange for your care to continue outside the study. What happens if the RAMPART study stops early?Very occasionally a study is stopped early. If this happens, the reasons will be explained to you and your doctor will arrange for your care to continue outside of the study. What if something goes wrong for me?If you have any concerns about the way you have been approached or treated during the study, please talk to your study doctor or nurse. If you are still unhappy, or if you wish to complain, please use the normal NHS complaints process. If you are harmed by taking part in the study, or if you are harmed because of someone’s negligence, then you may be able to take legal action. What will happen to the results of the RAMPART study?When the study is completed, we will publish a summary of the results on the website of the MRC CTU at UCL (ctu.mrc.ac.uk) and on the study website (rampart-)We will also publish the results in a medical journal, and present the information at medical conferences so that other doctors can see them. You can ask your doctor for a copy of any publication. Your identity and any personal details will be kept confidential. No named information about you will be published in any report of this study. We might want to keep you updated on the study and its progress. We will do this via short communications which the team at your local hospital will circulate as and when needed. You can also subscribe to newsletters via the trial website if you are happy for us to store your email address (held securely and separately from clinical data).11Contacts for further informationIf you want further information about the RAMPART study, contact your study doctor or nurse (see below). [Insert address and telephone number of study doctor and/or nurse]More information is also available on our website rampart-You can also find useful information on kidney cancer here:.uk.ukThank you for taking the time to consider taking part in this study.Table 1. Visit Plan Please note that the procedures highlighted in the table are additional for this study and are not part of routine care. # Pregnancy test will be performed on all women of childbearing potential at the start of the study and prior to each infusion.Table 2. List of expected side effects for durvalumab and tremelimumab The table below lists the most common or rare but severe side effects for durvalumab and tremelimumab and gives an indication of how likely it is that these side effects might occur: Very common:affects more than 1 in 10 patientsCommon:affects less than 1 in 10 patientsUncommon:affects less than 1 in 100 patientsRare:affects less than 1 in 1000 patientsVery rare:affects less than 1 in 10,000 patientsSome of the listed side effects may cause hospitalisation if they are sufficiently severe. If you become concerned about any side effects between hospital visits, please seek advice immediately from your nurse or doctor; contact details for your local team can be found in Section 11 of this information sheet).If you would like further information about any of these side effects you can ask your study doctor or nurse.Area AffectedSide EffectDurvalumabTremelimumabHeartAcute coronary syndromeRareRareCardiac arrestRareRareHeart failureRareRareHeart attack RareRareFluid around the heartRareRareAbnormal heart beatRareRareThyroid,Adrenal glands andPituitary glandOveractive thyroidCommonCommonInflammation of the thyroidCommonCommonThyroid hormones increasedCommonCommonDecreased activity of adrenal glandsUncommonRareDysfunction of the pituitary gland RareRareEyesBlurred visionUncommonUncommonInflammation of the eyeUncommonUncommonStomach and IntestinesDiarrhoeaCommonCommonInflammation of the bowelsUncommonCommonNauseaCommonCommonAbdominal PainCommonCommonInflammation of the mouthUncommonUncommonConstipationCommonCommonVomitingCommonCommonBuild-up of fluid in the membrane that lines the abdomen (tummy)RareRareDry mouthCommonCommonIndigestionUncommonUncommonDifficulty swallowingUncommonUncommonInflammation of the pancreasUncommonUncommonGeneral disordersFeverCommonCommonFatigueCommonCommonSwelling of legs/anklesUncommonCommonChillsUncommonUncommonPainRareRareCoughCommonCommonBreathing difficultyUncommonUncommonNose bleedsRareRareGall bladderInflammation of the gall bladderUncommonUncommonInfections Upper respiratory tract infectionRareRareUrinary tract infectionRareRareSepsis (severe infection)UncommonRareLiverInflammation of liver cells (hepatitis)RareRareAbnormal blood testsDecreased platelet countUncommonCommonDecreased white blood cell countUncommonUncommonBilirubin increased UncommonUncommonAspartate aminotransferase increasedUncommonUncommonNeutrophil count decreasedUncommonUncommonAmylase increasedCommonUncommonGamma-glutamyltransferase increasedUncommonUncommonAlanine aminotransferase increasedUncommonUncommonLipase increasedUncommonUncommonAlkaline phosphatase increasedUncommonUncommonMetabolism and NutritionIncreased triglyceridesUncommon UncommonDecreased sodiumUncommonUncommonHigh blood sugarRareRareDecreased magnesiumUncommonUncommonDecreased appetiteCommonCommonIncreased uric acid (causes gout)RareRareDecreased calciumRareRareDecreased potassiumRareRareDehydrationRareRareMuscles and bonesJoint painCommonCommonBack painCommonCommonMuscle painCommonUncommonWeakness or lack of energyCommonUncommonNervous system disordersDizzinessUncommonUncommonNerve painUncommonUncommon Changed sense of tasteUncommonUncommonNumbness or tingling in hands or feetUncommonUncommonTingling or prickling sensationUncommonUncommonPsychiatric disordersAnxietyUncommonUncommonDepressionUncommonUncommonDifficulty sleepingUncommonUncommonKidneysInflammation of the kidneysRareUncommonProtein in urineRareUncommonBlood in urineRareUncommonInflammation of the lungsUncommonUncommonFluid in the lungsUncommonUncommonRespiratory failureUncommonUncommonSkinHand-foot syndrome UncommonUncommonHair lossUncommonUncommonRashVery commonCommonItchy rashVery commonVery commonBlisterUncommonUncommonItchy skinVery commonCommonDry skinVery commonVery commonEczemaCommonCommonRedness of the skinVery commonVery commonVascular disordersNight sweatsUncommonUncommonHigh blood pressureUncommonUncommonLow blood pressureUncommonUncommonFlushingUncommonUncommonBlockage of blood vessels (Pulmonary embolism)UncommonRare Table 3. List of contraceptive methodsAll sexually active participants and partners of participants must use one of the followingIf you are female…If you are male…Barrier/Intrauterine methodsCopper T intrauterine deviceMale condom with spermicideLevonogesterel-releasing intrauterine system (e.g Mirena)Hormonal methodsEtonogestrel implants (e.g. Implanon or Norplan)Intravaginal device (e.g. ethinylestradiol and etonogestrel)Medroxyprogesterone injection (e.g. Depo-Provera)Normal and low dose combined oral contraceptive pillNorelgestromin/ethinylestradiol transdermal system (e.g. patches)Desogestrel (e.g. Cerazette) ................
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