Created at Source Raw Value Validated value
June 24, 2022, 1:30 p.m. usa

pregnancy or breastfeeding; health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: presence of inherited retinitis pigmentosa; presence or history of liver failure (child-pugh b or c); presence or history of stage 4 severe chronic kidney disease or dialysis requirement; febrile neutropenia; presence of end-stage cancer. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <50 ml/min; presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln; patient expected to be transferred to icu or die in the next 24 hours.

pregnancy or breastfeeding; health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: presence of inherited retinitis pigmentosa; presence or history of liver failure (child-pugh b or c); presence or history of stage 4 severe chronic kidney disease or dialysis requirement; febrile neutropenia; presence of end-stage cancer. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <50 ml/min; presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln; patient expected to be transferred to icu or die in the next 24 hours.

Jan. 23, 2022, 12:30 p.m. usa

pregnancy or breastfeeding; health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: presence of inherited retinitis pigmentosa; presence or history of liver failure; presence or history of stage 4 severe chronic kidney disease or dialysis requirement; febrile neutropenia; presence of end-stage cancer. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <50 ml/min; presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln; patient expected to be transferred to icu or die in the next 24 hours.

pregnancy or breastfeeding; health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: presence of inherited retinitis pigmentosa; presence or history of liver failure; presence or history of stage 4 severe chronic kidney disease or dialysis requirement; febrile neutropenia; presence of end-stage cancer. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <50 ml/min; presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln; patient expected to be transferred to icu or die in the next 24 hours.

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

pregnancy or breastfeeding; health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: presence of inherited retinitis pigmentosa; presence or history of liver failure; presence or history of stage 4 severe chronic kidney disease or dialysis requirement; febrile neutropenia; presence of active cancer treated with systemic chemotherapy or radiotherapy. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <60 ml/min. presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln.

pregnancy or breastfeeding; health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: presence of inherited retinitis pigmentosa; presence or history of liver failure; presence or history of stage 4 severe chronic kidney disease or dialysis requirement; febrile neutropenia; presence of active cancer treated with systemic chemotherapy or radiotherapy. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <60 ml/min. presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln.

Nov. 27, 2020, 12:31 a.m. usa

1. pregnancy or breastfeeding; 2. health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: 1. presence of inherited retinitis pigmentosa; 2. presence or history of liver failure; 3. presence or history of stage 4 severe chronic kidney disease or dialysis requirement; 4. febrile neutropenia; 5. presence of active cancer treated with systemic chemotherapy or radiotherapy. 3. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; 4. participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; 5. calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <60 ml/min. 6. presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln.

1. pregnancy or breastfeeding; 2. health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: 1. presence of inherited retinitis pigmentosa; 2. presence or history of liver failure; 3. presence or history of stage 4 severe chronic kidney disease or dialysis requirement; 4. febrile neutropenia; 5. presence of active cancer treated with systemic chemotherapy or radiotherapy. 3. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; 4. participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; 5. calculated creatinine clearance (crcl, using the cockroft-gault equation for example) <60 ml/min. 6. presence of total bilirubin >1.5 x uln (in the absence of demonstrated gilbert's syndrome), alt and/or ast > 2.5 x uln.

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

1. pregnancy or breastfeeding; 2. health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: 1. presence of inherited retinitis pigmentosa; 2. presence or history of liver failure; 3. presence or history of stage 4 severe chronic kidney disease or dialysis requirement; 4. febrile neutropenia; 5. presence of active cancer treated with systemic chemotherapy or radiotherapy. 3. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; 4. participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; 5. patient with known renal or hepatic impairment or patient with serum creatinine above 1.5 x upper limit of normal for each gender, as a marker of significant renal impairment, or an alt and/or ast above 5 x the upper limit of normal, as a marker of significant hepatic impairment.

1. pregnancy or breastfeeding; 2. health condition deemed to possibly interfere with the study endpoints and/or the safety of the patients. for example, the following conditions should be considered contraindicated for participation in the study, but this is not an exhaustive list. in case of doubt, the investigator should consult with the sponsor's medical representative: 1. presence of inherited retinitis pigmentosa; 2. presence or history of liver failure; 3. presence or history of stage 4 severe chronic kidney disease or dialysis requirement; 4. febrile neutropenia; 5. presence of active cancer treated with systemic chemotherapy or radiotherapy. 3. known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation proposed to be used in the study; 4. participation in another drug clinical trial within 30 days (or a minimum of 5 elimination half-lives) prior to screening, except ongoing participation in non-interventional studies; 5. patient with known renal or hepatic impairment or patient with serum creatinine above 1.5 x upper limit of normal for each gender, as a marker of significant renal impairment, or an alt and/or ast above 5 x the upper limit of normal, as a marker of significant hepatic impairment.