Safety
nausea, pharyngeal hypoesthesia, abdominal pain, pharyngeal swelling, treatment-emergent adverse, panic disorder, pain, dry throat, ileus
EVENTS, PHARYNGEAL HYPOESTHESIA, ILEUS
There were no relevant differences in vital signs or physical examination findings between the treatment groups. The incidence rates of TEAEs (treatment-emergent adverse events) in the ColdZyme group and the placebo group were comparable; 4.5% and 4.6% respectively. Two subjects had TEAEs with intensity "severe": one subject in the ColdZyme group had an ileus with abdominal pain, the only serious TEAE in the study, and one subject in the placebo group had a panic disorder. Likewise, the rate of events classified as adverse device effects was similar, with 1.4% subjects of the ColdZyme group and 2.3% of subjects of the placebo group having the highest relationship to the investigational product assessed as “related”. The events comprised nausea, oral pain, pharyngeal swelling, pharyngeal hypoesthesia, dry throat and panic disorder. At the end of the study an equal number of subjects rated the tolerability of the investigational product as either “very good” or “good”, 92.7% for ColdZyme and 93.5% for placebo (p = 0.145). The investigators’ rating of tolerability was “very good” or “good” for 91.9% of subjects in the ColdZyme group and 93.6% in the placebo group (p = 0.065).