Background
Objectives
Methods
Results
All (N=53) n (%) | Post-2004 (N=12) n (%) | |
---|---|---|
Reported total number who withdrew & withdrew due to AE | 48 (91) | 12 (100%) |
Reported that grading for AEs were assigned | 30 (57) | 9 (75) |
Reported mode of collection (e.g. questionnaire, patient reported, observation) | 23 (43) | 5 (42) |
Distinction between severe/life threatening AEs and those that were not. | 29 (55) | 11 (92) |
Reported the dictionary used for coding AEs | 1 (1.9) | 0 (0.0) |
Criteria | n (%) |
---|---|
Most frequent AEs | 17 (32) |
All AE’s that occurred | 17 (32) |
Other | 6 (11) |
A pre-specified list of AEs | 5 (9.4) |
Unclear | 3 (5.7) |
Not applicable as no AE reported | 3 (5.7) |
Any AE with sig diff between treatment groups | 2 (3.8) |