Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Effexor in a participant who received Effexor. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Effexor was assessed by the physician.

Time frame: 12 weeks from the start date (up until 52 weeks)

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Effexor at least once.

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or from 0 to 4 (9 items), and the total score ranges from 0 to 52, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Time frame: 12 weeks from the start date ( up until 52 weeks)

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), 1259 participants had available data at baseline.

MADRS is a clinician-administered rating scale that assesses the overall severity of depressive symptoms. The MADRS had a 10-item checklist (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are scored from 0 to 6, and the total score ranges from 0 to 60, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Time frame: 12 weeks from the start date ( up until 52 weeks)

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), 902 participants had available data at baseline.

CGI-I is a 7-point clinician-administered rating scale that assesses overall improvement of the disease/condition. The score ranges from 1 to 7, higher scores indicating more affected: was assessed as 1: markedly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: slightly worsened, 6: worsened, or 7: severely worsened. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Time frame: 12 weeks from the start date (up until 52 weeks)

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), those who had available data at Week 12 and 52 were evaluated.

CGI-S is a 7-point clinician-administered rating scale that assesses overall severity of the current illness state. The score ranges from 1 to 7, higher scores indicating more affected: 1: normal, not at all ill, 2: borderline mentally ill, 3: mildly ill, 4: moderately ill, 5: markedly ill, 6: severely ill, or 7: among the most extremely ill patients. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Time frame: 12 weeks from the start date (up until 52 weeks)

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), a cross tabulation of the patients with available baseline CGI-S scores by CGI-S scores Week 12 and Week 52 is described.