Clozaril® (clozapine) Tablets
Briefing
Document for Psychopharmacological Drugs Advisory Committee Meeting (
Appendix
3: Post-text Tables (Australian Data)
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Document status: |
Final |
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Release date: |
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Number of pages: |
8 |
Available for public disclosure without redaction
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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Post-text table 5.1-1
Summary
statistics for incidence of agranulocytosis [1]
All duration
__________________________________________________________________________________________________________________
Category
All duration
__________________________________________________________________________________________________________________
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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Post-text table 5.1-2
Summary
statistics for incidence of agranulocytosis [1]
By
duration of 1 - 18, 19 - 52, and > 52 weeks
__________________________________________________________________________________________________________________
-------------------------- Duration --------------------------
Category (0-18] Weeks (18-52] Weeks >52 Weeks
__________________________________________________________________________________________________________________
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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Post-text table 5.2-1
Summary
statistics for incidence of severe leukopenia [1]
All duration
__________________________________________________________________________________________________________________
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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Post-text table 5.2-2
Summary
statistics for incidence of severe leukopenia [1]
By duration of 1 - 18,
19 - 52, and > 52 weeks
__________________________________________________________________________________________________________________
-------------------------- 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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Post-text table 5.3-1
Summary statistics for
incidence of moderate leukopenia [1]
All duration
__________________________________________________________________________________________________________________
Category
All duration
__________________________________________________________________________________________________________________
Incidence/1000 patient
year
11.108
Number of incidence
390
Number of patient
9646
Total patient year
35111
__________________________________________________________________________________________________________________
[1] Moderate Leukopenia is defined as
WBC counts <= 3000/mm^3.
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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
__________________________________________________________________________________________________________________
--------------------------
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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