Table AD8.5.1.1

Treatment Emergent Adverse Experiences in Placebo-Controlled Study 212

(Reported by at least 1% of Patients Treated with Bupropion Sustained-Release in this study or at 1%

of Patients Treated with Bupropion Sustained-Release in the other Placebo-Controlled Phase 2-3 Trials

Summarized in Table 8.5.1.1)

BODY SYSTEM / ADVERSE EXPERIENCE

Bupropion sustained-release Dosing Group

150 mg/d

(N=147)

300 mg/d

(N=147)

Placebo

(N=150)

Psychiatric Disorders

Insomnia

6.1%

8.8%

5.3%

Agitation

2.0%

2.7%

2.0%

Anxiety

3.4%

4.8%

2.7%

Nervousness

5.4%

6.1%

3.3%

Somnolence

3.4%

2.7%

2.0%

Irritability

2.0%

2.0%

3.3%

Abnormal Dreams*

0.7%

0%

2.7%

CNS Stimulation

0%

0.7%

0%

Other Nervous System Disorders

Dizziness

7.5%

7.5%

6.0%

Tremor

3.4%

4.1%

1.3%

Hypertonia

1.4%

0.7%

0.7%

Digestive Tract Disorders

Dry Mouth

14.3%

17.0%

9.3%

Nausea

12.2%

15.0%

8.0%

Diarrhea

4.1%

5.4%

5.3%

Constipation

6.8%

9.5%

6.0%