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clinmed/2003010004v1/DC1
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TABLE 1

 

Intrinsic imputability score – chronological criterion ( C ) e

Time to appearance of event

 

Evolution when drug is

curtailed

Highly suggestive

(e.g. anaphylactic shock a few minutes after

injection ; fetal malformation for which

administration of suspect drug coincides with

the precise period during which involved

organ is formed)

Compatibility

(eczema-type reaction

occurring several days after

taking incompatible drug)

Incompatibility

(fixed pigmented

erythema occurring

several weeks after

taking drug)

suggestive

C3

C3

C1

C3

C2

C1

C0

Inconclusive

(regression which is spontaneous

or induced by non-specific

dermocorticoid anti-histaminic

symptomatic treatment,

irreversible lesions, insufficient follow- up, drug not curtailed

because essential)

 

 

 

C3

 

 

C2

 

 

C1

 

 

C3

 

 

C1

 

 

C1

 

 

C0

Non-suggestive

(absence of regression of

reversible type of event or complete regression despite

continuation of drug)

 

 

 

C1

 

 

C1

 

 

C1

 

 

C1

 

 

C1

 

 

C1

 

 

C0

+

0

-

+

0

-

0

Relapse during involuntary re-administration of drug

(0 = not performed )

Intrinsic imputability score – semiologic criterion (S)

semiology (clinical or para-

clinical) :

Other explanation not

attributable to drug :

Evocative of role of drug

( and / or highly suggestive factor)

Other semiologic possibilities

Absent (after appropriate work-

up )

S3

S3

S1

S3

S2

S1

Possible ( present or not sought)

S3

S2

S1

S3

S1

S1

+

0

-

+

0

-

Reliable specific complementary test ( 0 = test not available )

Intrinsic imputability score (I )

Chronology / Semiology

S1 doubtful

S2 plausible

S3 probable

C0 excluded

I0 excluded

C1 doubtful

I1 doubtful

I2 plausible

C2 plausible

I1

I2

I3

C3 probable

I3 probable

I4 very probable

 

Extrinsic imputability score (B)

B0 effect never published in inter-

national reference documents, even

after exhaustive bibliographic

search

B1 effect not described in international

reference works

B2 not well-known effect

published once or twice only,

different semiology or similar

drug

 

B3 well-known effect

described in the VIDAL dictionary or in reference works

 





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