Altogether 7 subjects (4.1% of the total population) discontinued due to reasons related to AEs (Table II).
In total we discontinued or did not prescribe antibiotics in 31/76 cases (41%) taking into consideration the results of PCT testing.
Adding infliximab to methotrexate also substantially improved the ultrasound findings in patient 6, leaving no residual PD signals in the synovial tissues even after the corticosteroid and the NSAID were discontinued (total intra-articular GS score, 20 versus 10; total intra-articular PD score, 7 versus 0; total tenosynovial GS score, 44 versus 6; total tenosynovial PD score, 24 versus 0).
In total, 25 patients discontinued study treatment early.
In total, seven patients discontinued treatment because of adverse events or intolerance to everolimus.
In total, five patients discontinued the study due to GI AEs, with these considered drug related in four patients.
In total, four patients discontinued treatment due to TEAEs (one AZD9773 patient each with cardiac arrest, sepsis and cerebral infarction, and atrial fibrillation in a placebo-treated patient).
These definitions were ventilation for ≥ 21 days in total, with ventilation discontinued for no more than 48 hours; and diagnosis-related group 541 and 542, involving mechanical ventilation for more than 96 hours and a tracheostomy.
The main group of interest was patients with PMV, which we defined in two different ways: DRG 541/542 (mechanical ventilation for ≥ 96 hours with placement of tracheostomy for non-head and neck diagnoses either with [DRG 541] or without [DRG 542] an operative diagnosis) and ventilation for ≥ 21 days total (with ventilation discontinued for no more than 48 hours).
A total of 17 patients discontinued early due to AEs (adjunctive armodafinil 150 mg/day, 7/200 (4 %); adjunctive placebo, 10/199 (5%%)).
A total of 17 patients discontinued the therapy due to the side effect of carbamazepine and another 10 patients underwent interventional or surgical treatments.
