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D PATIENT CHARACTERISTICS
This section describes the singular subject who experienced one or several adverse
events/reactions. As many patient characteristics as available (e.g. known) should be provided.
However, at least one data element in Section D must be populated with a meaningful value or
masked to fulfil the criteria ‘one identifiable patient’ (See Section 3.3.1).
At least one of the data elements in Section D must be populated with a meaningful
value or masked to fulfil the criteria ‘one identifiable patient’.
In cases where a foetus or breast-feeding infant is exposed to one or several drugs through the
parent and experienced one or several adverse events/reactions, information on both the parent
and the child/foetus should be provided. Reports of these cases are referred to as parent-
child/foetus reports. The following general principles should be used for filing these reports.
If there has been no event/reaction affecting the child/foetus, the parent-child/foetus report
does not apply e.g. the data elements in Section D apply only to the parent (mother or
father) who experienced the adverse reaction/event.
Example: Mother suffers from pre-eclampsia and the child has no adverse reaction.
Only one ICSR should be completed for the mother, with the adverse event/reaction of
pre-eclampsia. No events/reactions are reported for the child, therefore a linked ICSR
for the child is not applicable.
For those cases describing miscarriage, stillbirth or early spontaneous abortion, only a
mother report is applicable, e.g. the data elements in Section D apply to the mother.
However, if suspect drug(s) were taken by the father, this information should be indicated in
the data element G.k.10.r.
If both the parent and the child/foetus sustain adverse event(s)/reaction(s), two separate
reports, e.g. one for the parent (mother or father) and one for the child/foetus, should be
provided and should be linked by using the data element C.1.10.r in each report.
Example: Mother suffers from pre-eclampsia and, at parturition, the baby had a low
birth weight and club foot. Two linked ICSRs should be submitted: The mother’s report
should have the adverse event/reaction of pre-eclampsia the report for the baby should
have event/reaction terms for low birth weight and club foot. The term pre-eclampsia
would only apply to the mother’s case. The data element C.1.10.r should be completed
for both cases (e.g. the mother’s and baby’s).
If only the child/foetus has an adverse event/reaction (other than early spontaneous
abortion/foetal demise) the information provided in this section applies only to the
child/foetus, and characteristics concerning the parent (mother or father) who was the
source of exposure to the suspect drug should be provided in Section D.10.
Example: A report of foetal distress, where the mother delivered via a Caesarean
ICH ICSR Implementation Guide 12 April 2013
-72-
D PATIENT CHARACTERISTICS
This section describes the singular subject who experienced one or several adverse
events/reactions. As many patient characteristics as available (e.g. known) should be provided.
However, at least one data element in Section D must be populated with a meaningful value or
masked to fulfil the criteria ‘one identifiable patient’ (See Section 3.3.1).
At least one of the data elements in Section D must be populated with a meaningful
value or masked to fulfil the criteria ‘one identifiable patient’.
In cases where a foetus or breast-feeding infant is exposed to one or several drugs through the
parent and experienced one or several adverse events/reactions, information on both the parent
and the child/foetus should be provided. Reports of these cases are referred to as parent-
child/foetus reports. The following general principles should be used for filing these reports.
If there has been no event/reaction affecting the child/foetus, the parent-child/foetus report
does not apply e.g. the data elements in Section D apply only to the parent (mother or
father) who experienced the adverse reaction/event.
Example: Mother suffers from pre-eclampsia and the child has no adverse reaction.
Only one ICSR should be completed for the mother, with the adverse event/reaction of
pre-eclampsia. No events/reactions are reported for the child, therefore a linked ICSR
for the child is not applicable.
For those cases describing miscarriage, stillbirth or early spontaneous abortion, only a
mother report is applicable, e.g. the data elements in Section D apply to the mother.
However, if suspect drug(s) were taken by the father, this information should be indicated in
the data element G.k.10.r.
If both the parent and the child/foetus sustain adverse event(s)/reaction(s), two separate
reports, e.g. one for the parent (mother or father) and one for the child/foetus, should be
provided and should be linked by using the data element C.1.10.r in each report.
Example: Mother suffers from pre-eclampsia and, at parturition, the baby had a low
birth weight and club foot. Two linked ICSRs should be submitted: The mother’s report
should have the adverse event/reaction of pre-eclampsia the report for the baby should
have event/reaction terms for low birth weight and club foot. The term pre-eclampsia
would only apply to the mother’s case. The data element C.1.10.r should be completed
for both cases (e.g. the mother’s and baby’s).
If only the child/foetus has an adverse event/reaction (other than early spontaneous
abortion/foetal demise) the information provided in this section applies only to the
child/foetus, and characteristics concerning the parent (mother or father) who was the
source of exposure to the suspect drug should be provided in Section D.10.
Example: A report of foetal distress, where the mother delivered via a Caesarean