- Bradycardia (n=537)
3
- Hypotension (n=532)
12
- Significant Cardiovascular Events
1
• Abnormal ECG
- All Pts
23
- Pts with normal baseline (n=559)
14
• Peripheral Neuropathy
- Any symptoms
60
- Severe symptoms†
3
• Myalgia/Arthralgia
- Any symptoms
60
- Severe symptoms†
8
• Gastrointestinal
- Nausea and vomiting
52
- Diarrhea
38
- Mucositis
31
• Alopecia
87
• Hepatic (Pts with normal baseline and on study data)
- Bilirubin elevations (N=765)
7
- Alkaline phosphatase elevations (N = 575)
22
- AST (SGOT) elevations (N=591)
19
• Injection Site Reaction
13
a Based on worst course analysis.
b All patients received premedication.
c During the first 3 hours of infusion.
† Severe events are defined as at least Grade III toxicity.
None of the observed toxicities were clearly influenced by age.
Disease-Specific Adverse Event Experiences
Second-Line Ovary: For the 403 patients who received single-agent Paclitaxel Injection in the Phase 3 second-line ovarian carcinoma study, the following table shows the incidence of important adverse events.
Table 5: Frequencya of Important Adverse Events in the Phase 3 Second-Line Ovarian Carcinoma Study
Percent of Patients
175/3b (n=95)
175/24b (n=105)
135/3b (n=98)
135/24b (n=105)
• Bone Marrow
- Neutropenia < 2,000/mm3
78
98
78
98
< 500/mm3
27
75
14
67
- Thrombocytopenia < 100,000/mm3
4
18
8
6
< 50,000/mm3
1
7
2
1
- Anemia
