PMC:4235387 / 9617-10593 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/4235387","sourcedb":"PMC","sourceid":"4235387","source_url":"http://www.ncbi.nlm.nih.gov/pmc/4235387","text":"Outcome variables\nThe primary objective was the safety and tolerability of vortioxetine, as assessed on the basis of AEs, vital signs and weight, ECGs, clinical laboratory values, and physical examination findings. AEs were assessed for severity (mild, moderate, or severe) and causal relationship with the study drug (probable, possible, or not related). Treatment-emergent adverse events (TEAEs) were defined as an AE with an onset that occurred after receiving the study drug and within 30 days after receiving the last dose of the study drug. Suicidal ideation and behavior were assessed as an exploratory variable utilizing the C-SSRS. Change in the severity of symptoms of depression and anxiety were assessed using the mean change from the open-label baseline in HAM-D24 total score (at all visits) and the mean change from baseline in the MADRS total score, HAM-A total score, and CGI-S at weeks 4, 24, and 52. Patient-reported outcomes included the SF-36 and the SDS.","divisions":[{"label":"Title","span":{"begin":0,"end":17}}],"tracks":[{"project":"NEUROSES","denotations":[{"id":"T593","span":{"begin":679,"end":689},"obj":"PM3425"}],"attributes":[{"subj":"T593","pred":"source","obj":"NEUROSES"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"NEUROSES","color":"#95ec93","default":true}]}]}}