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What are the rows present in protocol Violation table?
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Answer Posted / ybchowdary
In the protocol violation table the following are the rows present in the table.
1.No of patients discontinued
2. protocol violation
3. protocol entry criteria not met
4. adverse events
5. last to followup
6. progressive disease
7. physician decision
8. sponsor decision
9. patient decision
10. death due to study disease
11. death due to study drug related
12. death due to procedural related
13. death due to adverse events (other causes)
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