Goose, I asked the same question of misiu143 (medi
Post# of 154134
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Posted On: 12/15/2020 1:23:52 PM
Re: Goosebumps #68214
Goose, I asked the same question of misiu143 (medical professional) over on Ihub -
Perhaps you can answer a question that has been nagging me. I keep seeing posters saying "2 weeks to analyze the data".
If the endpoint of the trial is mortality, why would it take 2 weeks to count how many participants are alive ?
Her reply -
Because it is more that to count how many died on the drug and how many in SOC
Every death need to be analyze in the details why ,
People could die due to car accident etc ..
I mean this is not a very smart example , but you get my point ..
Also there are few secondary , very important endpoints , they all need to be analyze ..,. I am not sure if 2 wks will be enough .,
I will say 2-3 weeks ...
Quite frankly, I would think that each patient chart would already be made up so that all the endpoint questions are on said chart, and it would just be a matter of collating said charts.
Here is a reminder of the Outcome Measures.
Primary Outcome Measures :
All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.
Secondary Outcome Measures :
1) All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.
2) Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
3) Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
4) Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]
The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
Perhaps you can answer a question that has been nagging me. I keep seeing posters saying "2 weeks to analyze the data".
If the endpoint of the trial is mortality, why would it take 2 weeks to count how many participants are alive ?
Her reply -
Because it is more that to count how many died on the drug and how many in SOC
Every death need to be analyze in the details why ,
People could die due to car accident etc ..
I mean this is not a very smart example , but you get my point ..
Also there are few secondary , very important endpoints , they all need to be analyze ..,. I am not sure if 2 wks will be enough .,
I will say 2-3 weeks ...
Quite frankly, I would think that each patient chart would already be made up so that all the endpoint questions are on said chart, and it would just be a matter of collating said charts.
Here is a reminder of the Outcome Measures.
Primary Outcome Measures :
All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.
Secondary Outcome Measures :
1) All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.
2) Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
3) Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
4) Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]
The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
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