I belive Bayer Vital GmbH (Regorafenib) was one of the "many" potential cancer partners, Dr. Kelly was talking for several years.
I think we are lucky this trial did not pan out, this seems to be a deal with the devil:
SAFETY INFORMATION
But it is interesting this trial was uploaded and a day later it was set to withdrawn. Is there any regulative necessity to post/ upload trials to clinicaltrials.org, even when they did not start or are withdrwan?
I think we are lucky this trial did not pan out, this seems to be a deal with the devil:
SAFETY INFORMATION
Quote:
STIVARGA may cause serious side effects, including:
Infection. STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung.
STIVARGA may lead to a higher risk of fungal infections of the mucous membrane, skin or the body. Tell your healthcare provider right away if you get fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, shortness of breath, burning or pain when urinating, unusual vaginal discharge or irritation, redness, swelling or pain in any part of the body
severe bleeding. STIVARGA can cause bleeding, which can be serious and sometimes lead to death. Tell your healthcare provider if you have any signs of bleeding while taking STIVARGA, including: vomiting blood or if your vomit looks like coffee grounds, pink or brown urine, red or black (looks like tar) stools, coughing up blood or blood clots, menstrual bleeding that is heavier than normal, unusual vaginal bleeding, nose bleeds that happen often, bruising, and lightheadednessa tear in your stomach or intestinal wall (bowel perforation).
STIVARGA may cause a tear in your stomach or intestinal wall that can be serious and sometimes lead to death . Contact your healthcare provider immediately if you notice severe pains or swelling in your stomach area (abdomen), fever, chills, nausea, vomiting, or dehydration
a skin problem called hand-foot skin reaction and severe skin rash. Hand-foot skin reactions are common and sometimes can be severe. Tell your healthcare provider right away if you get redness, pain, blisters, bleeding, or swelling on the palms of your hands and soles of your feet, or a severe rash
high blood pressure . Your blood pressure should be checked every week for the first 6 weeks of starting STIVARGA. Your blood pressure should be checked regularly and any high blood pressure should be treated while you are receiving STIVARGA. Tell your healthcare provider if you have severe headaches, light-headedness, or changes in your vision
decreased blood flow to the heart and heart attack. Get emergency help if you have chest pain, have shortness of breath, feel dizzy, or feel like passing out
a condition called reversible posterior leukoencephalopathy syndrome (RPLS) . Call your healthcare provider right away if you get severe headaches, seizure, confusion, change in vision, or problems thinkingrisk of wound healing problems. Wounds may not heal properly during STIVARGA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with STIVARGA.You should stop taking STIVARGA at least 2 weeks before planned surgery.Your healthcare provider should tell you when you may start taking STIVARGA again after surgery.
The most common side effects with STIVARGA include pain including stomach-area (abdomen); tiredness, weakness, fatigue; diarrhea (frequent or loose bowel movements); decreased appetite; infection; voice change or hoarseness; increase in certain liver function tests; fever; swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis); and weight loss.
But it is interesting this trial was uploaded and a day later it was set to withdrawn. Is there any regulative necessity to post/ upload trials to clinicaltrials.org, even when they did not start or are withdrwan?
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