n vs. Control) Arm 1
IFL + Placebo
(n = 396) Arm 2
IFL + Avastin
(n = 392)
a Central laboratories were collected on Days 1 and 21 of each cycle. Neutrophil counts are available in 303 patients in Arm 1 and 276 in Arm 2.
NCI‑CTC Grade 3–4 Events 74% 87%
Body as a Whole
Asthenia 7% 10%
Abdominal Pain 5% 8%
Pain 5% 8%
Cardiovascular
Hypertension 2% 12%
Deep Vein Thrombosis 5% 9%
Intra‑Abdominal Thrombosis 1% 3%
Syncope 1% 3%
Digestive
Diarrhea 25% 34%
Constipation 2% 4%
Hemic/Lymphatic
Leukopenia 31% 37%
Neutropeniaa 14% 21%
Table 2: NCI‑CTC Grade 1–4 Adverse Events in Study 1 (Occurring at Higher Incidence [≥ 5%] in IFL + Avastin vs. IFL)
Arm 1
IFL + Placebo
(n = 98) Arm 2
IFL + Avastin
(n = 102) Arm 3
5‑FU/LV + Avastin
(n = 109)
Body as a Whole
Pain 55% 61% 62%
Abdominal Pain 55% 61% 50%
Headache 19% 26% 26%
Cardiovascular
Hypertension 14% 23% 34%
Hypotension 7% 15% 7%
Deep Vein Thrombosis 3% 9% 6%
Digestive
Vomiting 47% 52% 47%
Anorexia 30% 43% 35%
Constipation 29% 40% 29%
Stomatitis 18% 32% 30%
Dyspepsia 15% 24% 17%
GI Hemorrhage 6% 24% 19%
Weight Loss 10% 15% 16%
Dry Mouth 2% 7% 4%
Colitis 1% 6% 1%
Hemic/Lymphatic
Thrombocytopenia 0% 5% 5%
Nervous
Dizziness 20% 26% 19%
Respiratory
Upper Respiratory Infection 39% 47% 40%
Epistaxis 10% 35% 32%
Dyspnea 15% 26% 25%
Voice Alteration 2% 9% 6%
Skin/Appendages
Alopecia 26% 32% 6%
Skin Ulcer 1% 6% 6%
Special Senses
Taste Disorder 9% 14% 21%
Urogenital
Proteinuria 24% 36% 36%
Table 3: NCI‑CTC Grade 1–4 Adverse Events in Study 6 (Occurring at Higher Incidence [≥5%] in Capecitabine + Avastin vs. Capecitabine Alone) Capecitabine
(n = 215) Capecitabine + Avastin
(n = 229)
Body as a Whole
Asthenia 47% 57%
Headache 13% 33%
Pain 25% 31%
Cardiovascular
Hypertension 2% 24%
Digestive
Stomatitis 19% 25%
Metabolic/Nutrition
Weight loss 4% 9%
Musculoskeletal
Myalgia 8% 14%
Respiratory
Dyspnea 18% 27%
Epistaxis 1% 16%
Skin/Appendages
Exfoliative dermatitis 75% 84%
Urogenital
Albuminuria 7% 22%
Table 4: NCI‑CTC Grades 1–5 Adverse Events in Study 9 (Occurring at Higher Incidence [≥5%] in IFN‑α + Avastin vs. IFN‑α + Placebo) System Organ Class/Preferred terma IFN‑α + Place |
