CLINICAL TRIAL PROTOCOL SPACE 2 Stent ... - SPACE-2 Studie

Clinical Trial Code: SPACE 2 Version: 10. October 2008 Final
5.2.2 Risk factor screening 19
5.2.3 Neurological examination 20
5.2.4 Drug history 20
5.2.5 Ultrasound examination 20
5.3 Treatment 20
5.3.1 Allocation to treatment 20
5.3.2 Best medical treatment 21
5.3.3 Carotid endarterectomy 21
5.3.4 Carotid artery stenting 21
5.4 Blinding 21
5.5 Follow-up examinations 21
5.6 Plan for treatment or care after the trial 22
6 Assesments 22
6.1 Definitions 22
6.2 Evaluation of Safety 23
6.3 Evaluation of efficacy 23
6.3.1 Primary endpoint 23
6.3.2 Secondary endpoints 23
6.3.3 Tertiary endpoints 24
6.4 Endpoint evaluation 24
7 Adverse Event reporting 24
7.1 Definitions 24
7.1.1 Adverse event 24
7.1.2 Serious adverse event 25
7.1.3 Expectedness 25
7.1.4 Outcome event 25
7.2 Period of observation and documentation 25
7.3 Reporting of SAEs by investigator 27
7.4 Reporting of OEs by the investigator 27
7.5 Expedited reporting 28
8 Data Management 28
8.1 Data collection 28
8.2 Data handling 28
8.3 Storage and archiving of data 29
9 Data analysis / statistical methods 29
9.1 Sample size calculation 29
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