|
Table 2. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder1 |
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|
Obsessive Compulsive Disorder |
Panic Disorder |
Social Anxiety Disorder |
||||||
|
PAXIL |
Placebo |
PAXIL |
Placebo |
PAXIL |
Placebo |
|||
| Body System | Preferred Term |
(n = 542) |
(n = 265) |
(n = 469) |
(n = 324) |
(n = 425) |
(n = 339) |
|
| Body as a Whole | Asthenia |
22% |
14% |
14% |
5% |
22% |
14% |
|
| Abdominal Pain |
— |
— |
4% |
3% |
— |
— |
||
| Chest Pain |
3% |
2% |
— |
— |
— |
— |
||
| Back Pain |
— |
— |
3% |
2% |
— |
— |
||
| Chills |
2% |
1% |
2% |
1% |
— |
— |
||
| Trauma |
— |
— |
— |
— |
3% |
1% |
||
| Cardiovascular | Vasodilation |
4% |
1% |
— |
— |
— |
— |
|
| Palpitation |
2% |
0% |
— |
— |
— |
— |
||
| Dermatologic | Sweating |
9% |
3% |
14% |
6% |
9% |
2% |
|
| Rash |
3% |
2% |
— |
— |
— |
— |
||
| Gastrointestinal | Nausea |
23% |
10% |
23% |
17% |
25% |
7% |
|
| Dry Mouth |
18% |
9% |
18% |
11% |
9% |
3% |
||
| Constipation |
16% |
6% |
8% |
5% |
5% |
2% |
||
| Diarrhea |
10% |
10% |
12% |
7% |
9% |
6% |
||
| Decreased | ||||||||
| Appetite |
9% |
3% |
7% |
3% |
8% |
2% |
||
| Dyspepsia |
— |
— |
— |
— |
4% |
2% |
||
| Flatulence |
— |
— |
— |
— |
4% |
2% |
||
| Increased | ||||||||
| Appetite |
4% |
3% |
2% |
1% |
— |
— |
||
| Vomiting |
— |
— |
— |
— |
2% |
1% |
||
| Musculoskeletal | Myalgia |
— |
— |
— |
— |
4% |
3% |
|
| Nervous System | Insomnia |
24% |
13% |
18% |
10% |
21% |
16% |
|
| Somnolence |
24% |
7% |
19% |
11% |
22% |
5% |
||
| Dizziness |
12% |
6% |
14% |
10% |
11% |
7% |
||
| Tremor |
11% |
1% |
9% |
1% |
9% |
1% |
||
| Nervousness |
9% |
8% |
— |
— |
8% |
7% |
||
| Libido Decreased |
7% |
4% |
9% |
1% |
12% |
1% |
||
| Agitation |
— |
— |
5% |
4% |
3% |
1% |
||
| Anxiety |
— |
— |
5% |
4% |
5% |
4% |
||
| Abnormal | ||||||||
| Dreams |
4% |
1% |
— |
— |
— |
— |
||
| Concentration | ||||||||
| Impaired |
3% |
2% |
— |
— |
4% |
1% |
||
| Depersonalization |
3% |
0% |
— |
— |
— |
— |
||
| Myoclonus |
3% |
0% |
3% |
2% |
2% |
1% |
||
| Amnesia |
2% |
1% |
— |
— |
— |
— |
||
| Respiratory System | Rhinitis |
— |
— |
3% |
0% |
— |
— |
|
| Pharyngitis |
— |
— |
— |
— |
4% |
2% |
||
| Yawn |
— |
— |
— |
— |
5% |
1% |
||
| Special Senses | Abnormal Vision |
4% |
2% |
— |
— |
4% |
1% |
|
| Taste Perversion |
2% |
0% |
— |
— |
— |
— |
||
| Urogenital System | Abnormal | |||||||
| Ejaculation2 |
23% |
1% |
21% |
1% |
28% |
1% |
||
| Dysmenorrhea |
— |
— |
— |
— |
5% |
4% |
||
| Female Genital | ||||||||
| Disorder2 |
3% |
0% |
9% |
1% |
9% |
1% |
||
| Impotence2 |
8% |
1% |
5% |
0% |
5% |
1% |
||
| Urinary | ||||||||
| Frequency |
3% |
1% |
2% |
0% |
— |
— |
||
| Urination | ||||||||
| Impaired |
3% |
0% |
— |
— |
— |
— |
||
| Urinary Tract | ||||||||
| Infection |
2% |
1% |
2% |
1% |
— |
— |
||
| 1.Events reported by at least 2% of OCD, panic disorder, and social anxiety disorder in patients treated with PAXIL are included, except the following events which had an incidence on placebo >PAXIL: [OCD]: Abdominal pain, agitation, anxiety,back pain, cough increased, depression, headache, hyperkinesia, infection, paresthesia, pharyngitis, respiratory disorder, rhinitis, and sinusitis. [panic disorder]: Abnormal dreams, abnormal vision, chest pain, cough increased, depersonalization, depression, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, myalgia, nervousness, palpitation, paresthesia, pharyngitis, rash, respiratory disorder, sinusitis, taste perversion, trauma, urination impaired, and vasodilation. [social anxiety disorder]: Abdominal pain, depression, headache, infection, respiratory disorder, and sinusitis. | ||||||||
| 2.Percentage corrected for gender. | ||||||||