Log in
RegisterAdverse event [Regulatives / Guidelines]
Hello ,
Can anyone clarify my doubt? Its urgent? In one of our study one subject was dosed at 09:06 and he got vomiting at 09:20. The Cmax of the drug was between 30min-6 hrs (median 2 hrs). Finally the subject was withdrwn from the study but the AE was given as not related with the drug? Plz Justify?
Can anyone clarify my doubt? Its urgent? In one of our study one subject was dosed at 09:06 and he got vomiting at 09:20. The Cmax of the drug was between 30min-6 hrs (median 2 hrs). Finally the subject was withdrwn from the study but the AE was given as not related with the drug? Plz Justify?
Complete thread:
- Adverse eventRameswari jena 2013-10-30 11:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adverse event ElMaestro 2013-10-30 12:15
- Adverse event Rameswari jena 2013-10-30 12:49
- Adverse event ElMaestro 2013-10-30 13:27
- Adverse event Dr_Dan 2013-10-30 14:48
- Adverse event jag009 2013-10-30 14:59
- Adverse event Rameswari jena 2013-10-30 12:49
- Adverse event Rameswari jena 2013-10-31 06:09
- Adverse event ElMaestro 2013-10-30 12:15
Ing. Helmut Schütz