Discontinued 8week randomized period Adverse event Condition worsened
Development of studyspecific discontinuation criteria
Eligibility criteria not fulfilled Severe noncompliance to the study protocol
Patient lost to followup Patient not willing to continue Other
Completed 8week
randomized treatment period
n=72 n=36 n=0 n=2 n=0 n=1 n=16 n=16 n=1
n=87 n=41 n=1 n=2 n=1 n=4 n=18 n=19 n=1
n=139 n=102 n=58
n=0 n=1 n=1 n=1 n=18 n=22 n=1
n=162 n=154
Enrolled in 2week drugdiscontinuation/
tapering phase n=137 n=130 n=118
a1 patient was randomized into the placebo group from another AstraZeneca study. This patient was included in the safety analysis set but excluded from the MITT and TDSS analysis sets; bn=1, n=2, n=3, n=3 patients were not treated in the placebo, quetiapine XR 50 mg/day, 150 mg/day and 300 mg/day groups, respectively. Patients not treated were also counted as discontinued from the 8week randomized treatment period.
n=104
n=119 n=117
n=70 n=15 n=1 n=3 n=2 n=6 n=21 n=21 n=1
n=165
n=142
n=128 Completed 10week study
Patients screened (n=1364)
Patients randomized (n=951)a Screen failures
Lost to followup Adverse event
Eligibility criteria not fulfilled Severe noncompliance Development of study specific discontinuation criteria
Patient not willing to continue Other
413 52 0 268 1 7 84 1
Quetiapine XR 300 mg/dayb
n=241 Quetiapine XR
50 mg/dayb n=234
Quetiapine XR 150 mg/dayb
n=241 Placebob
n=235 Supplemental Figure B. Patient disposition.
