therapy. Table 4 shows the percent of patients with clinical adverse experiences reported at an incidence ≥3%.
Table 4: Percent of Patients Receiving Highly Emetogenic Chemotherapy With Clinical Adverse Experiences (Incidence ≥3%) — Cycle 1 Aprepitant Regimen
(N=544) Standard Therapy
(N=550)
Body as a Whole/ Site Unspecified
Abdominal Pain
Asthenia/Fatigue
Dehydration
Dizziness
Fever
Mucous Membrane Disorder
4.6
17.8
5.9
6.6
2.9
2.6
3.3
11.8
5.1
4.4
3.5
3.1
Digestive System
Constipation
Diarrhea
Epigastric Discomfort
Gastritis
Heartburn
Nausea
Vomiting
10.3
10.3
4.0
4.2
5.3
12.7
7.5
12.2
7.5
3.1
3.1
4.9
11.8
7.6
Eyes, Ears, Nose, and Throat
Tinnitus
3.7
3.8
Hemic and Lymphatic System
Neutropenia
3.1
2.9
Metabolism and Nutrition
Anorexia
10.1
9.5
Nervous System
Headache
Insomnia
8.5
2.9
8.7
3.1
Respiratory System
Hiccups
10.8
5.6
In addition, isolated cases of serious adverse experiences, regardless of causality, of bradycardia, disorientation, and perforating duodenal ulcer were reported in highly emetogenic CINV clinical studies.
Moderately Emetogenic Chemotherapy
During Cycle 1 of a moderately emetogenic chemotherapy study, 438 patients were treated with the aprepitant regimen and 385 of these patients continued into the Multiple-Cycle extension for up to 4 cycles of chemotherapy. In Cycle 1, clinical adverse experiences were reported in approximately 73% of patients treated with the aprepitant regimen compared with approximately 75% of patients treated with standard therapy.
The adverse experience profile in the moderately emetogenic chemotherapy study was generally comparable to the highly emetogenic chemotherapy studies. Table 5 shows the percent of patients with clinical adverse experiences reported at an incidence ≥3%.
Table 5: Percent of Patients Receiving Moderately Emetogenic Chemotherapy With Clinical Adverse Experiences (Incidence ≥3%) — Cycle 1 Aprepitant Regimen
(N=438) Standard Therapy
(N=428)
Blood and Lymphatic System Disorders
Neutropenia
8.9
8.4
Metabolism and Nutrition Disorders
Anorexia
4.3
5.8
Psychiatric Disorders
Insomnia
4.1
5.6
Nervous System Disorders
Dizziness
Headache
3.4
16.4
4.2
16.4
Vascular Disorders
Hot Flush
3.0
1.4
Respiratory, Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain
3.0
2.3
Gastrointestinal Disorders
Constipation
Diarrhea
Dyspepsia
Nausea
Stomatitis
12.3
5.5
8.4
7.1
5.3
18.0
6.3
4.9
7.5
4.4
Skin and Subcutaneous Tissue Disorders
Alopecia
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