The SCIentinel study - prospective multicenter study to define the spinal cord injury-induced immune depression syndrome (SCI-IDS) - study protocol and interim feasibility data

Table 5 Administrative interim analysis of the completeness of laboratory data (flow cytometry) for each visit relative to the number of enrolled patients feasible for 'per protocol’ analysis

Groups		Visit 1	Visit 2	Visit 3	Visit 4	Visit 5
Overall n = 56	Complete data n	32	38	44	44	25
Overall n = 56	(% of 'per protocol’ population)	(57)	(68)	(79)	(79)	(45)
SCI T4 and above n = 28	Complete data n	17	20	22	22	16
SCI T4 and above n = 28	(% of 'per protocol’ population)	(61)	(71)	(79)	(79)	(57)
SCI T5 and below n = 11	Complete data n	6	6	8	10	5
SCI T5 and below n = 11	(% of 'per protocol’ population)	(55)	(55)	(73)	(91)	(45)
Control group n = 17	Complete data n	9	12	14	12	4
Control group n = 17	(% of 'per protocol’ population)	(53)	(71)	(82)	(71)	(24)

Legend: The completeness of the main laboratory data was calculated for the three groups relative to the number of enrolled patients feasible for 'per protocol’ analysis. The sample size calculation takes a 50% rate of drop out or missing values into account. Considering the drop out rate < 10% at the current stage of the trial, a 60% rate of data completeness is acceptable. Critical rates of overall completeness are observed at visit 1 and visit 5 and relate mainly to the control group and to patients with neurological level T5 or below.

ISSN: 1471-2377