Clozaril (clozapine) Tablets

 

Briefing Document for Psychopharmacological Drugs Advisory Committee Meeting (June 16, 2003)

 

 

Appendix 3: Post-text Tables (Australian Data)

 

 

 

 

 

Document status:

Final

Release date:

May 19, 2003

Number of pages:

8

 

 

Available for public disclosure without redaction


 

3 Post-text Tables

 

 

Post-text table 5.1-1 Summary statistics for incidence of agranulocytosis

 

Post-text table 5.1-2 Summary statistics for incidence of agranulocytosis by treatment duration of 0-18, 19-52, and > 52 weeks

 

Post-text table 5.2-1 Summary statistics for incidence of severe leukopenia

 

Post-text table 5.2-2 Summary statistics for incidence of severe leukopenia by treatment duration of 0-18, 19-52, and > 52 weeks

 

 

Post-text table 5.3-1 Summary statistics for incidence of moderate leukopenia

 

Post-text table 5.3-2 Summary statistics for incidence of moderate leukopenia by treatment duration of 0-18, 19-52, and > 52 weeks

 

 

 

 

 

 

 

 

 

 

 


 

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Clozaril (clozapine)

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Post-text table 5.1-1

Summary statistics for incidence of agranulocytosis [1]

All duration

Australia Data

 

 

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Category All duration

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Incidence/1000 patient year 1.445

Number of incidence 51

Number of patient 9646

Total patient year 35282

 

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[1] Agranulocytosis is defined as either WBC <= 1000/mm^3 or ANC <= 500/mm^3

 

 

 

 

 

 

 

 

 

 

 

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Novartis Pharmaceuticals Corporation Page 1 of 1

Clozaril (clozapine)

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Post-text table 5.1-2

Summary statistics for incidence of agranulocytosis [1]

By duration of 1 - 18, 19 - 52, and > 52 weeks

Australia Data

 

 

__________________________________________________________________________________________________________________

 

-------------------------- Duration --------------------------

Category (0-18] Weeks (18-52] Weeks >52 Weeks

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Incidence/1000 patient year 8.266 2.167 0.517

Number of incidence 26 11 14

Number of patient 9646 8484 7177

Total patient year 3145 5076 27061

 

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[1] Agranulocytosis is defined as either WBC <= 1000/mm^3 or ANC <= 500/mm^3

 

 

 

 

 

 

 

 

 

 

 

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Novartis Pharmaceuticals Corporation Page 1 of 1

Clozaril (clozapine)

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Post-text table 5.2-1

Summary statistics for incidence of severe leukopenia [1]

All duration

Australia Data

 

 

__________________________________________________________________________________________________________________

 

Category All duration

__________________________________________________________________________________________________________________

 

Incidence/1000 patient year 1.900

Number of incidence 67

Number of patient 9646

Total patient year 35272

 

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[1] Severe leukopenia is defined as WBC counts < 2000/mm^3.

 

 

 

 

 

 

 

 

 

 

 

 

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Novartis Pharmaceuticals Corporation Page 1 of 1

Clozaril (clozapine)

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Post-text table 5.2-2

Summary statistics for incidence of severe leukopenia [1]

By duration of 1 - 18, 19 - 52, and > 52 weeks

Australia Data

 

 

__________________________________________________________________________________________________________________

 

-------------------------- Duration --------------------------

Category (0-18] Weeks (18-52] Weeks >52 Weeks

__________________________________________________________________________________________________________________

 

Incidence/1000 patient year 12.719 1.576 0.702

Number of incidence 40 8 19

Number of patient 9646 8481 7177

Total patient year 3145 5076 27052

 

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[1] Severe Leukopenia is defined as WBC counts < 2000/mm^3.

 

 

 

 

 

 

 

 

 

 

 

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Novartis Pharmaceuticals Corporation Page 1 of 1

Clozaril (clozapine)

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Post-text table 5.3-1

Summary statistics for incidence of moderate leukopenia [1]

All duration

Australia Data

 

 

__________________________________________________________________________________________________________________

 

Category All duration

__________________________________________________________________________________________________________________

 

Incidence/1000 patient year 11.108

Number of incidence 390

Number of patient 9646

Total patient year 35111

 

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[1] Moderate Leukopenia is defined as WBC counts <= 3000/mm^3.

 

 

 

 

 

 

 

 

 

 

 

 

 

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Novartis Pharmaceuticals Corporation Page 1 of 1

Clozaril (clozapine)

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Post-text table 5.3-2

Summary statistics for incidence of moderate leukopenia [1]

By duration of 1 - 18, 19 - 52, and > 52 weeks

Australia Data

 

 

__________________________________________________________________________________________________________________

 

-------------------------- Duration --------------------------

Category (0-18] Weeks (18-52] Weeks >52 Weeks

__________________________________________________________________________________________________________________

 

Incidence/1000 patient year 52.544 11.849 6.132

Number of incidence 165 60 165

Number of patient 9646 8462 7159

Total patient year 3140 5064 26907

 

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[1] Moderate Leukopenia is defined as WBC counts <= 3000/mm^3.

 

 

 

 

 

 

 

 

 

 

 

 

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