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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

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

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