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. Author manuscript; available in PMC: 2009 Jun 29.
Published in final edited form as: N Engl J Med. 2008 Oct 30;359(26):2753–2766. doi: 10.1056/NEJMoa0804633

Table 3.

Subjects Who Withdrew from Treatment or the Study*

Variable Combination Therapy (N=140) Sertraline (N=133) Cognitive Behavioral Therapy (N=139) Placebo (N=76)
number (percent)
Withdrawal from treatment 1 (0.7) 7 (5.3) 0 3 (3.9)
Attributed to an adverse event 1 (0.7) 2 (1.5) 0 2 (2.6)
 Tremor 0 1 (0.8) 0 0
 Stomach pain 0 1 (0.8) 0 0
 Suicidal ideation 0 0 0 1 (1.3)
 Worsening symptoms 1 (0.7) 0 0 1 (1.3)
Other reason 0 5 (3.8) 0 1 (1.3)
 Improved symptoms 0 0 0 1 (1.3)
 Declined treatment 0 5 (3.8) 0 0
Withdrawal from study 12 (8.6) 16 (12.0) 6 (4.3) 12 (15.8)
Attributed to an adverse event 2 (1.4) 6 (4.5) 0 1 (1.3)
 Agitation or disinhibition 1 (0.7) 2 (1.5) 0 0
 Self-harm or homicidal ideation 0 1 (0.8) 0 0
 Hyperactivity 0 1 (0.8) 0 0
 Worsening symptoms 1 (0.7) 1 (0.8) 0 0
 Headache 0 1 (0.8) 0 0
 Rash 0 0 0 1 (1.3)
Other reason 10 (7.1) 10 (7.5) 6 (4.3) 11 (14.5)
 Lack of improvement 2 (1.4) 0 1 (0.7) 1 (1.3)
 Loss of contact 5 (3.6) 3 (2.3) 2 (1.4) 2 (2.6)
 Time burden 0 0 1 (0.7) 1 (1.3)
 Withdrawal of consent 3 (2.1) 7 (5.3) 1 (0.7) 6 (7.9)
 Other 0 0 1 (0.7) 1 (1.3)
*

Subjects who withdrew from treatment stopped receiving their assigned therapy but continued to undergo assessment; those who withdrew from the study stopped receiving their assigned treatment and did not undergo continued assessment.