Created at Source Raw Value Validated value
June 25, 2024, noon usa

* history of severe hypersensitivity to degarelix or any component of their respective formulation. * history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) \> 500 msec on electrocardiogram performed at screening. * planned discharge within 24 hours of treatment initiation. * subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. * ongoing usage of a class ia or class iii antiarrhythmic agent. at least 5 half lives must elapse since any prior use of a class ia or iii antiarrhythmic agent prior to administration of study drug. --baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. * myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. * enrollment in another investigational study within 30 days of day 1. * known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. * child-pugh class c liver disease. * use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. * unwilling or unable to comply with the study protocol. * any condition, which in the opinion of the investigator, would preclude participation in the trial.

* history of severe hypersensitivity to degarelix or any component of their respective formulation. * history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) \> 500 msec on electrocardiogram performed at screening. * planned discharge within 24 hours of treatment initiation. * subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. * ongoing usage of a class ia or class iii antiarrhythmic agent. at least 5 half lives must elapse since any prior use of a class ia or iii antiarrhythmic agent prior to administration of study drug. --baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. * myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. * enrollment in another investigational study within 30 days of day 1. * known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. * child-pugh class c liver disease. * use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. * unwilling or unable to comply with the study protocol. * any condition, which in the opinion of the investigator, would preclude participation in the trial.

Nov. 16, 2021, 6:30 p.m. usa

history of severe hypersensitivity to degarelix or any component of their respective formulation. history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. planned discharge within 24 hours of treatment initiation. subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. ongoing usage of a class ia or class iii antiarrhythmic agent. at least 5 half lives must elapse since any prior use of a class ia or iii antiarrhythmic agent prior to administration of study drug. --baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. enrollment in another investigational study within 30 days of day 1. known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. child-pugh class c liver disease. use of any of the following hormonal agents within day 1 of treatment: androgen receptor antagonists or agonists within 4 weeks, ketoconazole or abiraterone acetate within 2 weeks, estrogens or progestins within 2 weeks, herbal products that contain hormonally active agents within 2 weeks. unwilling or unable to comply with the study protocol. any condition, which in the opinion of the investigator, would preclude participation in the trial.

history of severe hypersensitivity to degarelix or any component of their respective formulation. history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. planned discharge within 24 hours of treatment initiation. subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. ongoing usage of a class ia or class iii antiarrhythmic agent. at least 5 half lives must elapse since any prior use of a class ia or iii antiarrhythmic agent prior to administration of study drug. --baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. enrollment in another investigational study within 30 days of day 1. known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. child-pugh class c liver disease. use of any of the following hormonal agents within day 1 of treatment: androgen receptor antagonists or agonists within 4 weeks, ketoconazole or abiraterone acetate within 2 weeks, estrogens or progestins within 2 weeks, herbal products that contain hormonally active agents within 2 weeks. unwilling or unable to comply with the study protocol. any condition, which in the opinion of the investigator, would preclude participation in the trial.

March 9, 2021, 12:31 a.m. usa

- history of severe hypersensitivity to degarelix or any component of their respective formulation. - history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. - planned discharge within 24 hours of treatment initiation. - subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - ongoing usage of a class ia or class iii antiarrhythmic agent. at least 5 half lives must elapse since any prior use of a class ia or iii antiarrhythmic agent prior to administration of study drug. --baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. - myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. - enrollment in another investigational study within 30 days of day 1. - known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. - child-pugh class c liver disease. - use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. - unwilling or unable to comply with the study protocol. - any condition, which in the opinion of the investigator, would preclude participation in the trial.

- history of severe hypersensitivity to degarelix or any component of their respective formulation. - history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. - planned discharge within 24 hours of treatment initiation. - subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - ongoing usage of a class ia or class iii antiarrhythmic agent. at least 5 half lives must elapse since any prior use of a class ia or iii antiarrhythmic agent prior to administration of study drug. --baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. - myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. - enrollment in another investigational study within 30 days of day 1. - known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. - child-pugh class c liver disease. - use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. - unwilling or unable to comply with the study protocol. - any condition, which in the opinion of the investigator, would preclude participation in the trial.

Dec. 7, 2020, 12:31 a.m. usa

- history of severe hypersensitivity to degarelix or any component of their respective formulation. - history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. - planned discharge within 24 hours of treatment initiation. - subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - chronic use of any drug known to prolong qt intervals within 30 days of day 1. one time use will be acceptable as long as there is sufficient time between drug administration and initiation of the study drug. this will be determined on a case by case basis under the discretion of the pi and/or co-investigators. an electrocardiogram will be performed to ensure a normal qtc value (qt interval corrected by the fridericia correction formula (qtcf)<500) - baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. - myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. - enrollment in another investigational study within 30 days of day 1. - known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. - child-pugh class c liver disease. - use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. - unwilling or unable to comply with the study protocol. - any condition, which in the opinion of the investigator, would preclude participation in the trial.

- history of severe hypersensitivity to degarelix or any component of their respective formulation. - history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. - planned discharge within 24 hours of treatment initiation. - subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - chronic use of any drug known to prolong qt intervals within 30 days of day 1. one time use will be acceptable as long as there is sufficient time between drug administration and initiation of the study drug. this will be determined on a case by case basis under the discretion of the pi and/or co-investigators. an electrocardiogram will be performed to ensure a normal qtc value (qt interval corrected by the fridericia correction formula (qtcf)<500) - baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. - myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. - enrollment in another investigational study within 30 days of day 1. - known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. - child-pugh class c liver disease. - use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. - unwilling or unable to comply with the study protocol. - any condition, which in the opinion of the investigator, would preclude participation in the trial.

Oct. 26, 2020, 11:31 p.m. usa

- history of severe hypersensitivity to degarelix or any component of their respective formulation. - active use of anti-viral therapies directed at sars-cov-2, except for remdesivir at the discretion of the treating physician. antibiotics not directed at sars-cov-2 are allowed. - history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. - planned discharge within 24 hours of treatment initiation. - subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - any concurrent use of systemic glucocorticoids within 30 days of day 1 (day of study drug administration). except with used in the treatment of covid-19 eg dexamethasone. - use of hydroxychloroquine, chloroquine or azithromycin within 30 days of day 1. - baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. - use of any drug known to prolong qt interval within 30 days of day 1. - myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. - enrollment in another investigational study within 30 days of day 1. - known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. - child-pugh class c liver disease. - use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. - unwilling or unable to comply with the study protocol. - any condition, which in the opinion of the investigator, would preclude participation in the trial.

- history of severe hypersensitivity to degarelix or any component of their respective formulation. - active use of anti-viral therapies directed at sars-cov-2, except for remdesivir at the discretion of the treating physician. antibiotics not directed at sars-cov-2 are allowed. - history of congenital long qt syndrome or known history of prolonged qt interval corrected by the fridericia correction formula (qtcf) > 500 msec on electrocardiogram performed at screening. - planned discharge within 24 hours of treatment initiation. - subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. - any concurrent use of systemic glucocorticoids within 30 days of day 1 (day of study drug administration). except with used in the treatment of covid-19 eg dexamethasone. - use of hydroxychloroquine, chloroquine or azithromycin within 30 days of day 1. - baseline electrolyte abnormalities of grade 3 or higher (based on ctcae v5.0 criteria). patients may be included if baseline electrolyte abnormalities are corrected to grade 2 or lower prior to study drug administration. - use of any drug known to prolong qt interval within 30 days of day 1. - myocardial infarction in the past 6 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease. - enrollment in another investigational study within 30 days of day 1. - known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. - child-pugh class c liver disease. - use of any of the following hormonal agents within day 1 of treatment: 1. androgen receptor antagonists or agonists within 4 weeks, 2. ketoconazole or abiraterone acetate within 2 weeks, 3. estrogens or progestins within 2 weeks, 4. herbal products that contain hormonally active agents within 2 weeks. - unwilling or unable to comply with the study protocol. - any condition, which in the opinion of the investigator, would preclude participation in the trial.