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A MedDRA LLT numeric code should be used for the ‘Indication’ (D.8.r.6b) and the ‘Reaction’
(D.8.r.7b).In the event of previous exposure to drug(s) or vaccine(s) without reaction, the
MedDRA code ‘No adverse effect’ should be used in the Reaction column. Imprecise dates can
be used for both start and end dates.
The designation of ‘r’ in this section indicates that each item is repeatable and that it
corresponds to the same ‘r’ in all subsections. A separate block (r) should be used for each
relevant drug term. For example, if two drugs are reported, the first drug would be described in
items D.8.1.1 through D.8.1.7 and the other drug would be described in items D.8.2.1 through
D.8.2.7.
Overall, a conservative approach should be taken and if there is any doubt, the product should
be considered a suspect drug. If there are critical or controversial issues to be discussed in
regard to this judgment they can be briefly mentioned in a narrative in Section H.
As a general principle all drugs that were completed /discontinued before the start
of the treatment with the suspect(ed) drug(s) should be included in the ‘Relevant
Past Drug History’ section (D.8). Any drug(s) that are not suspected of causing the
event or reaction and that are administered to the patient at the time of the reaction
should be listed as concomitant medication in Section G.
A history of allergy to a specific drug is preferably reported in Section D.8
‘Relevant Past Drug History’, using the suspect drug name and MedDRA terms in
the indication and reaction data elements. These data elements are often searchable
in most databases and thus this is the preferred option.
When a non-specific allergy is reported (e.g. ‘sulfa’ allergy is reported, but
unknown if to a sulphonamide antibiotic or to a sulfa-containing diuretic), this
information could be reported in Section D.7.1 ‘Structured information on relevant
medical history’ by using the LLT ‘Drug hypersensitivity’ (or a more descriptive
LLT) under ‘Disease /surgical procedure /etc.’, and the name of the drug under
‘comments’.
ICH ICSR Implementation Guide 12 April 2013
-86-
A MedDRA LLT numeric code should be used for the ‘Indication’ (D.8.r.6b) and the ‘Reaction’
(D.8.r.7b).In the event of previous exposure to drug(s) or vaccine(s) without reaction, the
MedDRA code ‘No adverse effect’ should be used in the Reaction column. Imprecise dates can
be used for both start and end dates.
The designation of ‘r’ in this section indicates that each item is repeatable and that it
corresponds to the same ‘r’ in all subsections. A separate block (r) should be used for each
relevant drug term. For example, if two drugs are reported, the first drug would be described in
items D.8.1.1 through D.8.1.7 and the other drug would be described in items D.8.2.1 through
D.8.2.7.
Overall, a conservative approach should be taken and if there is any doubt, the product should
be considered a suspect drug. If there are critical or controversial issues to be discussed in
regard to this judgment they can be briefly mentioned in a narrative in Section H.
As a general principle all drugs that were completed /discontinued before the start
of the treatment with the suspect(ed) drug(s) should be included in the ‘Relevant
Past Drug History’ section (D.8). Any drug(s) that are not suspected of causing the
event or reaction and that are administered to the patient at the time of the reaction
should be listed as concomitant medication in Section G.
A history of allergy to a specific drug is preferably reported in Section D.8
‘Relevant Past Drug History’, using the suspect drug name and MedDRA terms in
the indication and reaction data elements. These data elements are often searchable
in most databases and thus this is the preferred option.
When a non-specific allergy is reported (e.g. ‘sulfa’ allergy is reported, but
unknown if to a sulphonamide antibiotic or to a sulfa-containing diuretic), this
information could be reported in Section D.7.1 ‘Structured information on relevant
medical history’ by using the LLT ‘Drug hypersensitivity’ (or a more descriptive
LLT) under ‘Disease /surgical procedure /etc.’, and the name of the drug under
‘comments’.