9. Drug Safety Labeling Changes
http://goo.gl/FEoWsj 2008-01~2014-10 ,每個月一份清單
10. The 2*2 contingency table
Predc. Symptom Other symptom Total
Drug a b a + b
other drugs c d c + d
Total a + c b + d N = a + b +c + d
•For ADR signal detection
29. Lower and Upper approximations
• Singleton approximation
})(|{ XxKUxXP P
k
g
})(|{ XxKUxXP P
k
g
• Subset approximation
}),(,|),({ XxpKUxxpKXPK
s
}),(,|),({ XxPKUxxPKXP
K
S
• Concept approximation
}),(,|),({ XxPKXxxPKXPK
c
}),(,|),({ XxPKXxxPKXP
K
c
Lower approximation
Set X
Upper approximation
30. Incomplete
SRS data
Attribute set
P
Strength
Computation
• global
• local
Characteristic set
K(P, x)
• tolerance (don’t care)
• Similarity (lost)
Approximation PX
• singleton
• subset
• concept
known rule :
Predc , drug reaction
• Analyze the feasibility of the 12 different methods
Rough Set : Basic Idea
31. Example
the singleton approximation& global
ISR Age Gender Drug PT
1 ? ? d1 s1
2 a2 ? d2,d3 s1,s2
3 a1 g1 d1 s1
4 a1 g1 d2,d3 s1,s2
5 ? ? d2,d3 s1,s2
6 ? g2 d1 s1
7 ? g1 d1 s1
8 a1 g1 d3 s1,s2
}8{)8,(}4{)4,(
}73{)7,(}3{)3(
}6{)6,(}2{)2(
}542{)5,(}7631{)1(
PKPK
,PKP,K
PKP,K
,,PK,,,P,K
SS
SS
SS
SS
.)( ?,such thatallfor
),(),(ifonlyandif)(),(
axPa
ayaxPRyx S
Similarity characteristic relation:
32. Example
the singleton approximation& global
Gender = g1 PT = s1 other PT
Drug = d2 Xa={4} Xb={}
other drugs Xc={3,7,8} Xd={}
}8{)8,(}4{)4,(
}73{)7,(}3{)3(
}6{)6,(}2{)2(
}542{)5,(}7631{)1(
PKPK
,PKP,K
PKP,K
,,PK,,,P,K
SS
SS
SS
SS
dd
cc
bb
aa
XPXP
XPXP
XPXP
XPXP
}8,7,3,1{}8,7,3{
}4{}4{
})(|{ XxKUxXP P
k
g
})(|{ XxKUxXP P
k
g
33. Example
the singleton approximation& global
Gender = g1 PT = s1 other reactions
Drug = d2 [1, 1] 0
other drugs [3, 4] 0
)(
)(
PRR
)(
)(
bac
dca
bac
dca
333.1
)01(3
)04(1
PRR75.0
)01(4
)03(1
34. Experiment
No.
Rule
Drug Name Symptom
The suitable
of group
(Age or
Gender)
Marked
year in US
Year
withdrawn
in US
R1-1
AVANDIA
MYOCARDIAL
INFARCTION
18~ 1990 2010R1-2 DEATH
R1-3 CEREBROVASCULAR
ACCIDENT
R2
TYSABRI
PROGRESSIVE
MULTIFOCAL
LEUKOENCEPHALOPATH
Y
18~ 2004 2005
R3
ZELNORM
CEREBROVASCULAR
ACCIDENT Female 2002 2007