Importantly, adverse events, injection-site reactions, and antibody formation with insulin glargine were found to be comparable with NPH [ 75].
Adverse events of special interest included GI events, injection-site reactions (ISRs), cardiovascular events, hypoglycaemia [ 16], pancreatitis, thyroid tumours, potential SARs and immunogenicity.
Investigators will record adverse events, injection site reactions, angina episodes and clinical and laboratory parameters on the CRF at each study visit.
The majority of ExQW (84.5%) and ExBID (97.8%) patients did not experience any of the four common injection-site related adverse events (injection-site erythema, pruritus, urticaria, or rash) over the course of the studies.
The module is responsible for putting a particular vector entry in an event injection call.
It detects the next VM Entry and introduces an artificial software interrupt by an event injection.
Other injection-site-related adverse events included injection-site urticaria (0.7% vs. 0.4%) and injection-site rash (1.4% vs. 0.4%), both having no significant between-group differences in incidence rate.
We only report here on adverse events of injections that we know for certain were applied extra-articularly.
The most commonly reported injection-site-related adverse events were injection-site erythema [6.5% ExQW vs. 1.1% ExBID; between-group difference of 5.4% (2.2, 8.5)] and injection-site pruritus [11.9% vs. 1.1%; between-group difference of 10.8% (6.8, 14.8)].
But the events after injection of IL-2 at the site of tumors were similar to those after injection of IL-2 loaded microspheres in normal tissue.
