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G.k.8 Action(s) Taken with Drug
User Guidance This data element captures the action taken with the drug as a result of the
reaction(s) /event(s). The value ‘1’(Drug withdrawn), taken together with
the ‘Outcome of Reaction /Event at the Time of Last Observation’ (E.i.7),
describe the dechallenge. ‘Not applicable’ should be used in
circumstances such as when the patient has died or the treatment had been
completed prior to reaction(s) /event(s) or the ‘Characterisation of Drug
Role’ (G.k.1) is ‘Drug Not Administered’. When ‘Not applicable’ is used,
details should be captured in Section H.
Conformance Optional
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.15
Value Allowed Actions taken codes:
1=Drug withdrawn
2=Dose reduced
3=Dose increased
4=Dose not changed
0=Unknown
9=Not applicable
Business Rule(s)
G.k.9.i Drug-reaction(s) /Event(s) Matrix (repeat as necessary)
This section provides the means to transmit the degree of suspected relatedness of the drug (k)
with a suspect role to each reaction(s)/event(s) (i) in Section E. The repeating items (r) are used
to provide the assessment of relatedness by different sources or methods of assessment. For the
purpose of reporting, there is an implied suspicion of causality for spontaneous reports. It is
recognised that information concerning the relatedness, especially for spontaneous reports, is
often subjective and might not be available.
The following example illustrates the functionality contained in this section.
Assume the patient has had three adverse events: Event1, Event2, and Event3
The reporter provided assessment of causality for events Event1 and Event2, but not for
Event3. The reporter’s assessment of causality is based on overall impression, which the
sender codes as ‘global introspection’.
The sender provided two methods of causality assessment, one with an algorithm (coded
algorithm) and the other a Bayesian analysis (coded Bardi).
From the above there are 2 sets of data for the reporter (2_events X 1_method of
assessment) and 6 sets for the sender (3_events X 2_methods of assessment) for a total 8
sets of data.
The appropriate item with the ‘relatedness’ information is G.k.9.i.2.r.x (where x equals the 3 sub
data elements 1-3). Please note the sub data elements 1-3 are repeatable. For subsection
G.k.9.i.1, a technical reference to the reaction /event in E.i should be used. Subsections
G.k.9.i.2.r.1, G.k.9.i.2.r.2 and G.k.9.i.2.r.3 do not call for a standardised methodology or
vocabulary.
ICH ICSR Implementation Guide 12 April 2013
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G.k.8 Action(s) Taken with Drug
User Guidance This data element captures the action taken with the drug as a result of the
reaction(s) /event(s). The value ‘1’(Drug withdrawn), taken together with
the ‘Outcome of Reaction /Event at the Time of Last Observation’ (E.i.7),
describe the dechallenge. ‘Not applicable’ should be used in
circumstances such as when the patient has died or the treatment had been
completed prior to reaction(s) /event(s) or the ‘Characterisation of Drug
Role’ (G.k.1) is ‘Drug Not Administered’. When ‘Not applicable’ is used,
details should be captured in Section H.
Conformance Optional
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.15
Value Allowed Actions taken codes:
1=Drug withdrawn
2=Dose reduced
3=Dose increased
4=Dose not changed
0=Unknown
9=Not applicable
Business Rule(s)
G.k.9.i Drug-reaction(s) /Event(s) Matrix (repeat as necessary)
This section provides the means to transmit the degree of suspected relatedness of the drug (k)
with a suspect role to each reaction(s)/event(s) (i) in Section E. The repeating items (r) are used
to provide the assessment of relatedness by different sources or methods of assessment. For the
purpose of reporting, there is an implied suspicion of causality for spontaneous reports. It is
recognised that information concerning the relatedness, especially for spontaneous reports, is
often subjective and might not be available.
The following example illustrates the functionality contained in this section.
Assume the patient has had three adverse events: Event1, Event2, and Event3
The reporter provided assessment of causality for events Event1 and Event2, but not for
Event3. The reporter’s assessment of causality is based on overall impression, which the
sender codes as ‘global introspection’.
The sender provided two methods of causality assessment, one with an algorithm (coded
algorithm) and the other a Bayesian analysis (coded Bardi).
From the above there are 2 sets of data for the reporter (2_events X 1_method of
assessment) and 6 sets for the sender (3_events X 2_methods of assessment) for a total 8
sets of data.
The appropriate item with the ‘relatedness’ information is G.k.9.i.2.r.x (where x equals the 3 sub
data elements 1-3). Please note the sub data elements 1-3 are repeatable. For subsection
G.k.9.i.1, a technical reference to the reaction /event in E.i should be used. Subsections
G.k.9.i.2.r.1, G.k.9.i.2.r.2 and G.k.9.i.2.r.3 do not call for a standardised methodology or
vocabulary.