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nullFlavor: MSK, ASKU, NASK, UNK
Business Rule(s)
If the relevant medical history is unknown to the sender (e.g. not
reported), this data element should be left blank with nullFlavor =UNK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.7. 3 Concomitant Therapies
User Guidance This data element indicates at the time of the reaction there were
concomitant therapies such as radiotherapy, drug class, dietary
supplements or other products not otherwise describable in Section G.
When this data element is set to ‘true’, details should be provided in the
narrative Section H.1.
Conformance Optional
Data Type Boolean
OID None
Value Allowed True
Business Rule(s)
In case of concomitant medication(s) the structured information on the medicinal
product(s) should be provided in Section G. In case of other administered therapies
that cannot be structured in Section G, then the data element D.7.3 is set to true and
details are provided in the narrative Section H.1.
D.8.r Relevant Past Drug History (repeat as necessary)
This section concerns relevant drugs previously administered and which have been stopped
before the Adverse Event onset. It does not concern drugs taken concomitantly or drugs which
might have potentially been involved in the current reaction(s)/event(s). Medical judgment
should be exercised in completing this section. Medications that have been stopped might be
considered suspect based on the elimination half-life of the drug and the known
pharmacodynamic effects of the drug in a particular patient (for example, a patient with known
renal or liver impairment).Information concerning concomitant and other suspect drugs should
be included in Section G. The information provided here can also include previous experience
with similar drugs.
To standardise this information, the ICH M5 IG also should be used. Based on the medicinal
product name as reported by the primary source, the most specific identifier, being either the
Medicinal Product Identifier (MPID) or the Pharmaceutical Product Identifier (PhPID), should
be provided. If a MPID or a PhPID for the reported medicinal product is not available, these
data elements should be left blank.
ICH ICSR Implementation Guide 12 April 2013
-85-
nullFlavor: MSK, ASKU, NASK, UNK
Business Rule(s)
If the relevant medical history is unknown to the sender (e.g. not
reported), this data element should be left blank with nullFlavor =UNK.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.7. 3 Concomitant Therapies
User Guidance This data element indicates at the time of the reaction there were
concomitant therapies such as radiotherapy, drug class, dietary
supplements or other products not otherwise describable in Section G.
When this data element is set to ‘true’, details should be provided in the
narrative Section H.1.
Conformance Optional
Data Type Boolean
OID None
Value Allowed True
Business Rule(s)
In case of concomitant medication(s) the structured information on the medicinal
product(s) should be provided in Section G. In case of other administered therapies
that cannot be structured in Section G, then the data element D.7.3 is set to true and
details are provided in the narrative Section H.1.
D.8.r Relevant Past Drug History (repeat as necessary)
This section concerns relevant drugs previously administered and which have been stopped
before the Adverse Event onset. It does not concern drugs taken concomitantly or drugs which
might have potentially been involved in the current reaction(s)/event(s). Medical judgment
should be exercised in completing this section. Medications that have been stopped might be
considered suspect based on the elimination half-life of the drug and the known
pharmacodynamic effects of the drug in a particular patient (for example, a patient with known
renal or liver impairment).Information concerning concomitant and other suspect drugs should
be included in Section G. The information provided here can also include previous experience
with similar drugs.
To standardise this information, the ICH M5 IG also should be used. Based on the medicinal
product name as reported by the primary source, the most specific identifier, being either the
Medicinal Product Identifier (MPID) or the Pharmaceutical Product Identifier (PhPID), should
be provided. If a MPID or a PhPID for the reported medicinal product is not available, these
data elements should be left blank.