Log in
RegisterShould pregnancy be considered as SAE? [Study Performance]
Dear Ratnakar,
Pregnancy is not per se an adverse event... One exception I would see to this is the situation where it is due to a drug-drug interaction with the contraceptive taken by the subject, leading to an unwanted pregnancy (or inefficiency of a IUD due to an anti-inflammatory effect, for instance).
Yes, certainly, as a congenital anomaly or birth defect would be a SAE.
Pregnancy is not per se an adverse event... One exception I would see to this is the situation where it is due to a drug-drug interaction with the contraceptive taken by the subject, leading to an unwanted pregnancy (or inefficiency of a IUD due to an anti-inflammatory effect, for instance).
❝ Should it be [...] followed up till the birth of the child
Yes, certainly, as a congenital anomaly or birth defect would be a SAE.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Should pregnancy be considered as SAE? ratnakar1811 2014-06-19 08:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Should pregnancy be considered as SAE?Ohlbe 2014-06-19 11:21
- Should pregnancy be considered as SAE? ElMaestro 2014-06-19 19:33
- Should pregnancy be considered as SAE? Ohlbe 2014-06-19 22:40
- Should pregnancy be considered as SAE? ElMaestro 2014-06-20 00:49
- Should pregnancy be considered as SAE? ratnakar1811 2014-06-20 11:14
- Should pregnancy be considered as SAE? mittyri 2014-07-22 19:33
- Should pregnancy be considered as SAE? ratnakar1811 2014-06-20 11:14
- Should pregnancy be considered as SAE? ElMaestro 2014-06-20 00:49
- Should pregnancy be considered as SAE? Ohlbe 2014-06-19 22:40
Ing. Helmut Schütz