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Adverse Events
The overall safety evaluation of NEXAVAR is based on 1286 cancer patients who
received NEXAVAR as monotherapy and 165 patients who received NEXAVAR
concurrently with chemotherapy. A total of 346 patients were exposed to NEXAVAR
monotherapy for greater than 6 months . A total of 664 RCC patients received
NEXAVAR monotherapy, of whom 215 were treated for at least 6 months. A full
presentation of safety information is provided in the Product Monograph.
Clinically significant adverse events included hypertension (17% for sorafenib vs 2% for
placebo), hemorrhage (15% sorafenib vs 8% for placebo), and cardiac ischemia /
infarction (2.9% for sorafenib vs 0.4% for placebo).
In a randomized, placebo-controlled study in locally advanced / metastatic RCC, the most
common treatment-emergent adverse events reported with sorafenib vs placebo were rash
(40% vs 16%), diarrhea (43% vs 13%), hand-foot skin reaction (30% vs 7%), fatigue
(37% vs 28%), and hypertension (17% vs 2%). Most adverse events observed with
NEXAVAR were CTCAE (National Cancer Institute Common Terminology Criteria for
Adverse Events) Grade 1 and 2. CTCAE Grade 4 drug-related adverse events were rare,
reported in 7% of patients receiving NEXAVAR compared to 6% of patients receiving
placebo.