(handwritten: Rm 1 David)
Addendum
to Review and Evaluation of Clinical Data:
Summary
of Protocol 212 For Wellbutrin SR NDA
This addendum summarizes data received on December 27, 1994 pertaining to clinical efficacy trial of Wellbutrin SR #212.
The
number of sections and tables below corresponds to that in the main body of the
Review and Evaluation of Clinical Data for this NDA.
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CONTENTS |
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AD5.1.1 Study Type and Design/Patient
Enumeration ..................................... |
1 |
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AD5.1.2 Demographics ..................................................................................... |
2 |
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AD5.1.3 Extent of Exposure (dose/duration) .................................................... |
3 |
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AD7.0 |
Efficacy
Findings .................................................................................................................. |
3 |
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AD7.1
Overview of Study 212 .......................................................................................... |
3 |
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AD7.2.3 Study 212 ............................................................................................ |
3 |
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AD7.2.3.1 Investigators and Location .......................................... |
3 |
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AD7.2.3.2 Study Plan ................................................................... |
4 |
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AD7.2.3.3 Study Conduct and Outcome ...................................... |
5 |
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AD7/2/3/4 Conclusion .................................................................. |
9 |
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AD7.3.2
Size of Treatment Effect ........................................................................ |
9 |
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AD8.0 |
Safety Findings ..................................................................................................................... |
9 |
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AD8.1 Methods
................................................................................................................ |
9 |
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AD8.2 Deaths
................................................................................................................... |
9 |
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AD8.3 Assessments
of Dropouts ...................................................................................... |
10 |
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AD8.3.1 Overall Patterns of Dropouts .............................................................. |
10 |
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AD8.3.2 Adverse Events Associated with Dropout .......................................... |
10 |
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AD8.4 Safety
Findings Discovered with Other Specific Search Strategies ..................... |
11 |
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AD8.5 Other
Safety Finding ............................................................................................. |
12 |
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AD8.5.1 ADE Incidence Tables ........................................................................ |
12 |
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AD8.5.3 Weight ................................................................................................. |
18 |
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AD8.6 Summary
of Important Adverse Events Considered Drug Related ...................... |
18 |
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AD8.7 Summary
of Other Important Adverse Events Considered Not Drug Related ..... |
18 |
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AD10.0 |
Conclusions
.......................................................................................................................... |
18 |
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