Saturday, 8 October 2011

Adverse Event Report





Report  1

Date : Month  dd, yyyy                                                                                                   Page  x of  n


  Treatment –expected Adeverse Events in Descreding Order of Frequency


_____________________________________________________________________________

expected Adeverse Event Term              Col – 5  mg            Col – 10 mg           Col – 15 mg            
                                                                  (N= xxx)                  (N=xxx)                  (N=xxx)
_____________________________________________________________________________
 
Number of Patients With
expected Adeverse Event (s)  xxx          xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)


 GROUP100                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

 GROUP200                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

 GROUP300                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

_____________________________________________________________________________
                                                               












Report  2

Date : Month  dd, yyyy                                                                                                   Page  x of  n


  Treatment –expected Adeverse Event list in Descreding Order of Frequency


_____________________________________________________________________________

expected Adeverse Event Term             Col – 5  mg            Col – 10 mg           Col – 15 mg            
                                                                  (N= xxx)                  (N=xxx)                  (N=xxx)
_____________________________________________________________________________
 
Number of Patients With
   expected Adeverse Event (s)  xxx        xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)


 GROUP100                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

    Exevent1                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Exevent2                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Exevent3                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)



GROUP200                                             xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

    Exevent1                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Exevent2                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Exevent3                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

GROUP300                                             xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

    Exevent1                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Exevent2                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Exevent3                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)             _____________________________________________________________________________
                                                               

Report  3

Date : Month  dd, yyyy                                                                                                   Page  x of  n


  Treatment –Unexpected Adeverse Events in Descreding Order of frequency


_____________________________________________________________________________

Unexpected Adeverse Event Term          Col – 5  mg            Col – 10 mg           Col – 15 mg            
                                                                  (N= xxx)                  (N=xxx)                  (N=xxx)
_____________________________________________________________________________
 
Number of Patients With
Unexpected Adeverse Event (s)  xxx     xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)


 GROUP100                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

 GROUP200                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

 GROUP300                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

_____________________________________________________________________________


















Report  4

Date : Month  dd, yyyy                                                                                                   Page  x of  n


 Treatment –Unexpected Adeverse Event list in Descreding Order of Frequency


_____________________________________________________________________________

Unexpected Adeverse Event Term           Col – 5  mg            Col – 10 mg           Col – 15 mg            
                                                                   (N= xxx)                  (N=xxx)                  (N=xxx)
_____________________________________________________________________________
 
Number of Patients With
Unexpected Adevent Event (s)  xxx        xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)


 GROUP100                                             xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

    Uxevent1                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Uxevent2                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Uxevent3                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)



GROUP200                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

    Uxevent1                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Uxevent2                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Uxevent3                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

GROUP300                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

    Uxevent1                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Uxevent2                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
    Uxevent3                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)             _____________________________________________________________________________
                                                               
Report  5

Date : Month  dd, yyyy                                                                                                   Page  x of  n


  Treatment –Serious Adevent Events in Descreding Order of Frequency


_____________________________________________________________________________

Serious Adverse Event Term                  Col – 5  mg            Col – 10 mg           Col – 15 mg            
                                                                  (N= xxx)                  (N=xxx)                  (N=xxx)
_____________________________________________________________________________
 
Number of Patients With
Serious  Adeverse Event (s)  xxx          xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)


 GROUP100                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

 GROUP200                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

 GROUP300                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

_____________________________________________________________________________

















Report  6

Date : Month  dd, yyyy                                                                                                   Page  x of  n


 Treatment – Serious Adeverse Event list in Descreding Order of Frequency


_____________________________________________________________________________

Serious Adeverse Event Term                 Col – 5  mg            Col – 10 mg           Col – 15 mg            
                                                                  (N= xxx)                  (N=xxx)                  (N=xxx)
_____________________________________________________________________________
 
Number of Patients With
Serious Adeverse  Event (s)  xxx          xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)


 GROUP100                                          xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

   Sxevent1                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
   Sxevent2                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
   Sxevent3                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)



GROUP200                                            xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

   Sxevent1                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
   Sxevent2                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
   Sxevent3                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

GROUP300                                           xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)

   Sxevent1                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
   Sxevent2                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)
   Sxevent3                                              xxx( xx.x%)            xxx(xx.x%)               xxx(xx.x%)             _____________________________________________________________________________
                                                               








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