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ICH ICSR Implementation Guide 12 April 2013
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D.2.2 Age at Time of Onset of Reaction /Event
If several reactions/events are in the report, the age at the time of the first reaction/event should
be used. For foetal reaction(s)/event(s), the Gestation Period When Reaction/ Event Was
Observed in the Foetus (D.2.2.1) should be used.
When providing the age in decades, please note that, for example, the 7th decade refers to a
person in his/her 60’s.
D.2.2a Age at Time of Onset of Reaction /Event (number)
User Guidance See Section D.2.2.
Conformance Optional, but required if D.2.2b is populated.
Data Type 5N
OID None
Value Allowed Numeric
Business Rule(s)
D.2.2bAge at Time of Onset of Reaction /Event (unit)
User Guidance See Section D.2.2.
Conformance Optional, but required if D.2.2a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.26
Value Allowed UCUM codes for Year, Month, Week, Day, and Hour: {Decade}
Business Rule(s)
The gestation period at the time of exposure is captured in Section G.k.6.
D.2.2.1a Gestation Period When Reaction /Event Was Observed in the Foetus (number)
User Guidance This data element captures the value (quantity) for the gestation period
when the reaction/event was observed in the foetus.
Conformance Optional, but required if D.2.2.1b is populated.
Data Type 3N
OID None
Value Allowed Numeric
Business Rule(s)