Population exposure-response modeling of oral Nepadutant administration in Colicky infants

August 2015 e115 mild to moderate AEs were mild to moderate infections (upper and lower respiratory tract most commonly), abnormal liver enzyme tests and infusion reaction or local reaction at the injection site. Of severe AEs, two cases of reactivation of tuberculosis, one case of colon carcinoma and one hospitalization due to the febrile state was observed. Conclusion: Our data confirm that anti-TNF therapy can be considered safe, as most of the AEs were mild to moderate in severity. However, vigilant follow-up of patients during and after the therapy is needed for early recognition and treatment of severe AEs.