Monday, August 02, 2010 11:51:55 PM
Moby, you don't necessarily know what any of that means. For example, explain how the following from one of the bavi studies:
http://investorshub.advfn.com/boards/post_reply.aspx?message_id=52898681
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Control: Uncontrolled
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients With Refractory Advanced Solid Tumor Malignancies
Resource links provided by NLM:
MedlinePlus related topics: Cancer
Drug Information available for: Immunoglobulins Bavituximab Globulin, Immune
U.S. FDA Resources
Further study details as provided by Peregrine Pharmaceuticals:
Primary Outcome Measures:
adverse events [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
laboratory evaluations [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
human anti-chimeric antibody [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
pharmacokinetic analysis [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
tumor evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
How is it possible that the primary and secondary outcome measures both indicate "Designated as safety issue: No" when the endpoint classification is "safety study"?
I think you've put too many eggs in the "Designated as safety issue" basket.
http://investorshub.advfn.com/boards/post_reply.aspx?message_id=52898681
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Control: Uncontrolled
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients With Refractory Advanced Solid Tumor Malignancies
Resource links provided by NLM:
MedlinePlus related topics: Cancer
Drug Information available for: Immunoglobulins Bavituximab Globulin, Immune
U.S. FDA Resources
Further study details as provided by Peregrine Pharmaceuticals:
Primary Outcome Measures:
adverse events [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
laboratory evaluations [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
human anti-chimeric antibody [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
pharmacokinetic analysis [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
tumor evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
How is it possible that the primary and secondary outcome measures both indicate "Designated as safety issue: No" when the endpoint classification is "safety study"?
I think you've put too many eggs in the "Designated as safety issue" basket.
