Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1. Pregnancy or lactation <br/ >2. History of allergy or hypersensitivity to any other treatment component based on <br/ >investigators assessment <br/ >3. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 <br/ >mL/min/1.73m2 <br/ >by the Modification of Diet in Renal Disease (MDRD) equation <br/ >4. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus <br/ >(HBV) or Hepatitis C virus (HCV) infection <br/ >5. Abnormal laboratory findings at screening <br/ >ï?· Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >ï?· Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >ï?· Absolute neutrophil count <500/mm3 <br/ >or permicroliter <br/ >ï?· Platelet count <100,000 per microliter or /mm3 <br/ >6. Patients who received a platelet transfusion in the 5 days prior to enroll. <br/ >7. Has any condition for which, in the opinion of the investigator, participation <br/ >would not be in the best interest of the participant or that could prevent, limit, or <br/ >confound the protocol-specified assessments including but not limited to: <br/ >ï?· Participants who are not expected to survive longer than 48 hours at the time <br/ >of randomization, or <br/ >ï?· with patient on ventilator <br/ >ï?· Previous history of Thoracic RT. <br/ >ï?· History of hemodynamic intolerability <br/ >ï?· CT finding with fibrotic changes <br/ >ï?· Female patients with family history of breast cancer.

1. Pregnancy or lactation <br/ >2. History of allergy or hypersensitivity to any other treatment component based on <br/ >investigators assessment <br/ >3. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 <br/ >mL/min/1.73m2 <br/ >by the Modification of Diet in Renal Disease (MDRD) equation <br/ >4. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus <br/ >(HBV) or Hepatitis C virus (HCV) infection <br/ >5. Abnormal laboratory findings at screening <br/ >ï?· Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >ï?· Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >ï?· Absolute neutrophil count <500/mm3 <br/ >or permicroliter <br/ >ï?· Platelet count <100,000 per microliter or /mm3 <br/ >6. Patients who received a platelet transfusion in the 5 days prior to enroll. <br/ >7. Has any condition for which, in the opinion of the investigator, participation <br/ >would not be in the best interest of the participant or that could prevent, limit, or <br/ >confound the protocol-specified assessments including but not limited to: <br/ >ï?· Participants who are not expected to survive longer than 48 hours at the time <br/ >of randomization, or <br/ >ï?· with patient on ventilator <br/ >ï?· Previous history of Thoracic RT. <br/ >ï?· History of hemodynamic intolerability <br/ >ï?· CT finding with fibrotic changes <br/ >ï?· Female patients with family history of breast cancer.

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Sept. 8, 2021, 1:30 a.m. oms

1. Pregnancy or lactation <br/ >2. History of allergy or hypersensitivity to any other treatment component based on <br/ >investigators assessment <br/ >3. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 <br/ >mL/min/1.73m2 <br/ >by the Modification of Diet in Renal Disease (MDRD) equation <br/ >4. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus <br/ >(HBV) or Hepatitis C virus (HCV) infection <br/ >5. Abnormal laboratory findings at screening <br/ >ï?· Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >ï?· Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >ï?· Absolute neutrophil count <500/mm3 <br/ >or permicroliter <br/ >ï?· Platelet count <100,000 per microliter or /mm3 <br/ >6. Patients who received a platelet transfusion in the 5 days prior to enroll. <br/ >7. Has any condition for which, in the opinion of the investigator, participation <br/ >would not be in the best interest of the participant or that could prevent, limit, or <br/ >confound the protocol-specified assessments including but not limited to: <br/ >ï?· Participants who are not expected to survive longer than 48 hours at the time <br/ >of randomization, or <br/ >ï?· with patient on ventilator <br/ >ï?· Previous history of Thoracic RT. <br/ >ï?· History of hemodynamic intolerability <br/ >ï?· CT finding with fibrotic changes <br/ >ï?· Female patients with family history of breast cancer.

1. Pregnancy or lactation <br/ >2. History of allergy or hypersensitivity to any other treatment component based on <br/ >investigators assessment <br/ >3. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 <br/ >mL/min/1.73m2 <br/ >by the Modification of Diet in Renal Disease (MDRD) equation <br/ >4. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus <br/ >(HBV) or Hepatitis C virus (HCV) infection <br/ >5. Abnormal laboratory findings at screening <br/ >ï?· Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >ï?· Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >ï?· Absolute neutrophil count <500/mm3 <br/ >or permicroliter <br/ >ï?· Platelet count <100,000 per microliter or /mm3 <br/ >6. Patients who received a platelet transfusion in the 5 days prior to enroll. <br/ >7. Has any condition for which, in the opinion of the investigator, participation <br/ >would not be in the best interest of the participant or that could prevent, limit, or <br/ >confound the protocol-specified assessments including but not limited to: <br/ >ï?· Participants who are not expected to survive longer than 48 hours at the time <br/ >of randomization, or <br/ >ï?· with patient on ventilator <br/ >ï?· Previous history of Thoracic RT. <br/ >ï?· History of hemodynamic intolerability <br/ >ï?· CT finding with fibrotic changes <br/ >ï?· Female patients with family history of breast cancer.