SERTRALINE HYDROCHLORIDE (Page 11 of 16)

Associated with Discontinuation in Placebo-Controlled Clinical Trials

Table 4 lists the adverse events associated with discontinuation of sertraline hydrochloride treatment (incidence at least twice that for placebo and at least 1% for sertraline hydrochloride in clinical trials) in major depressive disorder/other *, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.

TABLE 4 MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION IN PLACEBO-CONTROLLED CLINICAL TRIALS
Adverse Event Major Depressive Disorder/Other *, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined(N=2799) Major Depressive Disorder/ Other *(N=861) OCD(N=533) Panic Disorder(N=430) PTSD(N=374) PMDDDaily Dosing(N=121) PMDDLuteal Phase Dosing(N=136) Social Anxiety Disorder(N=344)
*
Major depressive disorder and other premarketing controlled trials.
Primarily ejaculatory delay. Denominator used was for male patients only (N=271 major depressive disorder/other*; N=296 OCD; N=216 panic disorder; N=130 PTSD; No male patients in PMDD studies; N=205 social anxiety disorder).
Abdominal Pain 1%
Agitation 1% 2%
Anxiety 2%
Diarrhea/ Loose Stools 2% 2% 2% 1% 2%
Dizziness 1%
Dry Mouth 1%
Dyspepsia 1%
Ejaculation Failure 1% 1% 1% 2% N/A N/A 2%
Fatigue 2%
Headache 1% 2% 1% 2%
Hot Flushes 1%
Insomnia 2% 1% 3% 2% 1% 3%
Nausea 3% 4% 3% 3% 2% 2% 1% 2%
Nervousness 2%
Palpitation 1%
Somnolence 1% 1% 2% 2%
Tremor 2%

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