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See Table 2 for a comparison of the most common adverse events following one and six week titration regimens. Table 2. Comparison of rates of adverse events in patients
titrated to 10 mg/day over 1 and 6 weeks
No titration
One week titration
Six week titration
Adverse Event
Placebo (n=315)
5 mg/day (n=311)
10 mg/day (n=315)
10 mg/day (n=269)
Nausea
6%
5%
19%
6%
Diarrhea
5%
8%
15%
9%
Insomnia
6%
6%
14%
6%
Fatigue
3%
4%
8%
3%
Vomiting
3%
3%
8%
5%
Muscle cramps
2%
6%
8%
3%
Anorexia
2%
3%
7%
3%
Text Continues Below
Adverse Events Reported in Controlled Trials The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 3 lists treatment emergent signs and symptoms that were reported in at least 2% of patients in placebo-controlled trials who received ARICEPT® and for which the rate of occurrence was greater for ARICEPT®-assigned than placebo-assigned patients. In general, adverse events occurred more frequently in female patients and with advancing age. Table 3. Adverse Events Reported in Controlled Clinical Trials
in at Least 2% of Patients Receiving ARICEPT® and at a Higher Frequency than Placebo-treated Patients
Body System/Adverse Event
Placebo (n=355)
ARICEPT® (n=747)
Percent of Patients with any Adverse Event
72
74
Body as a Whole
Headache
9
10
Pain, various locations
8
9
Accident
6
7
Fatigue
3
5
Cardiovascular System
Syncope
1
2
Digestive System
Nausea
6
11
Diarrhea
5
10
Vomiting
3
5
Anorexia
2
4
Hemic and Lymphatic System
Ecchymosis
3
4
Metabolic and Nutritional Systems
Weight Decrease
1
3
Musculoskeletal System
Muscle Cramps
2
6
Arthritis
1
2
Nervous System
Insomnia
6
9
Dizziness
6
8
Depression
<1
3
Abnormal Dreams
0
3
Somnolence
<1
2
Urogenital System
Frequent Urination
1
2
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