Data

Data

The very first patients to try Gleevec were about 760, in different countries. There aren't really any controlled trials that can show a clinical benefit like an increased survival, as that will need years of analysis. Though there has been reason to think that there is very high chance of benefits.
The approval by the FDA was based on this data, studied on three Phase II open-label, single arm studies which showed a MAJOR CYTOGENETIC response in patient with advanced stages of CML (complete = 0% Ph+ metaphases or partial = up to 35% Ph+ metaphases).
21% In the accelerated phase
14% In myeloid blast crisis
49% For patients in Chronic phase, after the Interferon therapy had failed. These patients have achieved an 88% HEMATOLOGIC response.

Right now 7500 people are using Gleevec in 490 sites in 30 different countries.
Here is some side effects statistics:
-Nausea (55-68%)
-Fluid Retention (52-68%)
-Muscle Cramps (25-46%)
-Diarrhea (33-49%)
-Vomiting (28-54%)
-Hemoorrhage (13-48%)
-Muscoloskeletal pain (27-39%)
-Skin rash (32-39%)
-Headache (24-28%)
-Fatigue (24-33%)
--MORE SERIOUS--
-SEVERE EDEMA (1-5%)
-ELEVATED LIVER ENZYMES (1.1-3.5%)
-HEMORRAGES (0.4-16%)
Nevertheless, we shall not forget that interferon-alpha treatment's side effects are even worse and don't give nearly the same results.