01 Was study design clear? |
15 (100%) |
02 Were methods used to identify ADRs described in detail? |
7
(47%) |
03 Were data collection methods clearly described? |
12
(80%) |
04 Were the individuals who identified ADRs clearly described? |
10
(67%) |
05 Was the process of establishing the causal relationship described in
detail? |
8 (53%) |
06 Were standard methods used in causality assessment? |
13
(87%) |
07 Was the process of establishing avoidability described in detail? |
7
(47%) |
08 Were standard methods used in avoidability assessment? |
7
(47%) |
09 Was the process of establishing seriousness or severity described in
detail? |
5 (33%) |
10 Were standard methods used in seriousness or severity assessment? |
8
(53%) |