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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) |
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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 ) |
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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 |
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Absent (after appropriate work- up ) |
S3 |
S3 |
S1 |
S3 |
S2 |
S1 |
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Possible ( present or not sought) |
S3 |
S2 |
S1 |
S3 |
S1 |
S1 |
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|
+ |
0 |
- |
+ |
0 |
- |
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Reliable specific complementary test ( 0 = test not available ) |
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Intrinsic imputability score (I ) |
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Chronology / Semiology |
S1 doubtful |
S2 plausible |
S3 probable |
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C0 excluded |
I0 excluded |
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C1 doubtful |
I1 doubtful |
I2 plausible |
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C2 plausible |
I1 |
I2 |
I3 |
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C3 probable |
I3 probable |
I4 very probable |
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Extrinsic imputability score (B) |
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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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