Table 1
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) |