8.5
Other
Safety Findings
8.5.1
ADE
Incidence Tables
Treatment
emergent adverse experiences were considered adverse experiences that emerged
or worsened following the beginning of the treatment phase. All investigator terms were converted by the
sponsor to COSTART terms.
|
Table 8.5.1.1 Treatment Emergent Adverse
Experiences in Placebo-Controlled Phase 2-3 Trials (Reported by at least 1%
of Patients Treated with Bupropion Sustained-Release) |
|||
|
BODY SYSTEM / ADVERSE
EXPERIENCE |
Bupropion sustained-release
Dosing Group |
||
|
100-200 mg/d (N=350) |
300-400 mg/d (N=343) |
Placebo (N=235) |
|
|
Psychiatric
Disorders |
|||
|
Insomnia |
9.7% |
14.0% |
7.2% |
|
Agitation |
2.6% |
5.0% |
1.7% |
|
Anxiety |
4.6% |
5.2% |
3.4% |
|
Nervousness |
3.4% |
3.2% |
2.1% |
|
Somnolence |
2.6% |
1.5% |
1.7% |
|
Irritability |
4.0% |
2.9% |
0.4% |
|
Abnormal
Dreams* |
2.6% |
1.5% |
2.1% |
|
CNS
Stimulation |
0% |
2.0% |
0.9% |
|
Other
Nervous System Disorders |
|||
|
Dizziness |
9.4% |
7.9% |
5.1% |
|
Tremor |
3.7% |
6.1% |
0.4% |
|
Hypertonia |
1.4% |
0.6% |
0.4% |
|
Digestive
Tract Disorders |
|||
|
Dry
Mouth |
12.9% |
19.5% |
5.5% |
|
Nausea |
10.3% |
13.7% |
7.2% |
|
Constipation |
8.3% |
9.0% |
7.2% |
*This
category primarily represents nightmares, but also includes vivid dreams, and
there changes in dream patterns.
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