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. Author manuscript; available in PMC: 2015 Apr 1.
Published in final edited form as: Clin Trials. 2014 Apr;11(2):159–166. doi: 10.1177/1740774513517184

Table 1.

Reasons for initial and terminal screen failure.

Failure Reason Initial screen
failure, n (%)
Rescreened after initial failure

Second
failure, n
(%)
Exclusion
resolved for
inclusion, n
(%)
Total rescreened,
n (%)
Total number of
participants
176 (100) 4 (2.2) 55 (31) 59 (33.5)
Exacerbation within 30
days
32 (18.2) 1 (25) 16 (29.1)
< 2 exacerbations in
prior 3 years
22 (12.5) 6 (10.9)
Other medical condition 19 (10.8) 1 (25) 5 (9.1)
Abnormal lab value 17 (9.7) 1 (25) 7 (12.7)
Inconclusive for / Not
RRMS
13 (7.4) 1 (1.8)
Unable to have MRI/Gad
sensitivity
7 (4.0) 2 (3.6)
EDSS > 5.5 2 (1.1) 1 (25)
Other reason* 64 (36.3) 18 (32.7)
*

Other non-medical reasons, including: site error, exceeding screening window, and participant decision