Table of Contents
PPT Slide
Alemtuzumab BLA committee
CD52 Expression
Expression on Other Cell Types
Antibody History
CAMPATH-1H (Alemtuzumab)
History of Submission
History of Submission
Pharmacokinetics Comment
Clinical Trials
Supporting Trials
Study Design
Study Design
Study Design
Study Design
Study Design
Study Design
Demographics
Rai Staging System
Rai Stage
Eligibility
Disposition
Efficacy Information
Responses, Response Rate
Response Measures
Responder Characteristics
Other Efficacy Parameters
Other Efficacy Parameters
Other Efficacy Parameters
Resolution in Symptoms in Responders
Safety Data
Dose Delays: > Seven Days
Reasons for Dose Delays > Seven Days
Mortality
Drug Related Causes of Death
Discontinuations
Serious Adverse Events
211: Analysis of Heme / Infectious SAEs, Stage I / II
211: Analysis of Hem and Infectious SAEs, Stage III / IV
Opportunistic Infections
Types of Serious OIs
Infusional Toxicities:All Grades
Infusional Toxicities: Gr. 3/4
Premedications
New Malignancies / Transformations
Hematological Toxicity
211 Heme Toxicity: Hgb
211 Heme Toxicity: Hemoglobin
211Hem Toxicity : Neutrophils
211 Hem Toxicity: Neutrophils
211 Heme Toxicity : Platelets
Heme Toxicity: 211- Platelets
211 Hem Toxicity: Two Month Follow-Up
Blood Product Usage
CD4+ Counts < 200/?l
SUMMARY
SUMMARY
SUMMARY
SUMMARY
SUMMARY
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