1
Of five reported serious AEs, none were considered related to study drug.
2
Serious AEs were reported for four patients, of which one was considered drug-related.
3
There were no serious AEs in any of the study arms.
4
The overall incidence of treatment-related and serious AEs remained stable or declined through study year 7.
5
No serious AEs were reported, and no subject withdrew from the study because of an AE.
6
Neither the severe AE nor any of the three serious AEs was considered related to sapropterin.
7
No serious AEs were observed in this study.
8
Serious AEs were seen in four patients.
9
Serious AEs using the Mogen clamp are rare, but do occur and require efficient, reliable emergency back-up.
10
No vaccine-related serious AEs were noted.
11
There were no serious AEs.
12
No serious AEs occurred.
13
Serious AEs were reported in 14.3% of patients; one event of dehydration was considered related to vismodegib.
