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G.k.5a Cumulative Dose to First Reaction (number)
G.k.5b Cumulative Dose to First Reaction (unit)
User Guidance This data element captures the unit for the value in G.k.5a.
Conformance Optional, but required if G.k.5a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.25
Value Allowed Constrained UCUM codes: {DF}
Business Rule(s)
UCUM allows using non-unit expression for symbols not in UCUM. In
this case, {DF} can be used in XML message.
G.k.6a Gestation Period at Time of Exposure (number)
User Guidance This data element captures the number for the gestational age at the time
of the earliest exposure.
Conformance Optional, but required if G.k.6b is populated.
Data Type 3N
OID None
Value Allowed Numeric
Business Rule(s)
The gestational age is expressed in terms of days, weeks, months or
trimester (G.k.6b).
G.k.6b Gestation Period at Time of Exposure (unit)
User Guidance This data element captures the unit for the value in G.k.6a.
Conformance Optional, but required if G.k.6a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.26
Value Allowed UCUM codes for Month, Week, and Day:{Trimester}
Business Rule(s)
Units commonly used in clinical practice but not defined in UCUM can
be transmitted using curly braces like e.g. {trimester}.
User Guidance This data element captures the value (amount) cumulative dose
administered until the onset of the first sign, symptom or reaction/event.
Conformance Optional, but required if G.k.5b is populated.
Data Type 10N
OID None
Value Allowed Numeric
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
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G.k.5a Cumulative Dose to First Reaction (number)
G.k.5b Cumulative Dose to First Reaction (unit)
User Guidance This data element captures the unit for the value in G.k.5a.
Conformance Optional, but required if G.k.5a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.25
Value Allowed Constrained UCUM codes: {DF}
Business Rule(s)
UCUM allows using non-unit expression for symbols not in UCUM. In
this case, {DF} can be used in XML message.
G.k.6a Gestation Period at Time of Exposure (number)
User Guidance This data element captures the number for the gestational age at the time
of the earliest exposure.
Conformance Optional, but required if G.k.6b is populated.
Data Type 3N
OID None
Value Allowed Numeric
Business Rule(s)
The gestational age is expressed in terms of days, weeks, months or
trimester (G.k.6b).
G.k.6b Gestation Period at Time of Exposure (unit)
User Guidance This data element captures the unit for the value in G.k.6a.
Conformance Optional, but required if G.k.6a is populated.
Data Type 50AN
OID 2.16.840.1.113883.3.989.2.1.1.26
Value Allowed UCUM codes for Month, Week, and Day:{Trimester}
Business Rule(s)
Units commonly used in clinical practice but not defined in UCUM can
be transmitted using curly braces like e.g. {trimester}.
User Guidance This data element captures the value (amount) cumulative dose
administered until the onset of the first sign, symptom or reaction/event.
Conformance Optional, but required if G.k.5b is populated.
Data Type 10N
OID None
Value Allowed Numeric
Business Rule(s)