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The most frequent adverse event was itching, reported by two patients in the crystalloid group and three patients in the HES group.
The majority of AEs were of mild or moderate intensity; severe AEs were experienced by two patients in the fluticasone/formoterol group (2.0%).
Two events considered to be DLTs (grade 3 fatigue, and concomitant grade 3 diarrhoea and intermittent muscle cramps) were reported by two patients in the 90-mg (30 mg t.d.s).s
The medications were well tolerated, except for dyspepsia reported by three patients in the P. emblica 500 mg group and headache reported by two patients in the atorvastatin group.
Narcotic analgesics, either hydrocodone or codeine in combination with acetaminophen, were taken for rescue therapy by two patients in cohort 1, both assigned to placebo, two in cohort 2, one each on chicory and placebo.
Asthma (defined as asthma worsening and/or asthma exacerbation) was the most frequent SAE, reported by two patients in the QMF group (0.3%) and nine patients in the MF group (1.2%) (see online supplementary table S1 and appendix section 7).
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These were experienced by eight patients in the placebo group and by one patient with tifacogin.
Bisacodyl was used by nine patients in the PEG group and 10 in the lactulose group.
This dose level was well tolerated by eight patients in total (two new, six reduced) (Table 2).
Serious infections were reported by four patients in the tocilizumab and two in the methotrexate group (p = 0.422; table 4).
A mild subjective sense of flushing and palpitation during the first 3 days of treatment was reported by five patients in the Memo group and by three patients in the control group (P > 0.05).
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