Safety reporting
death, adverse drug reactions, disability/incapacity
ADVERSE EVENTS, ADVERSE EVENT, EVENTS, EVENTS, ADVERSE DRUG REACTIONS
Safety data were summarized for both treatment groups and summary statistics reported. Any events documented in the period from the point of treatment initiation until the last week of treatment (week-12, V10) were considered as relevant to the safety analysis.Adverse events: all observed or volunteered AEs, regardless of treatment group or suspected causal relationship to the study drug, were recorded. Events involving adverse drug reactions and illnesses with onset during the study were recorded. For all AEs, sufficient information was obtained by the investigator to determine the causality of the AEs.Serious adverse events: all SAEs (as defined below) regardless of treatment group or suspected relationship to the study drug were reported immediately. A SAE is any adverse drug experience occurring at any dose that (1) results in death, (2) is life-threatening, (3) results in hospitalization or prolongation of existing hospitalization, and (4) results in a persistent or significant disability/incapacity.