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Documentation and analysis of adverse event data in clinical trials: The German chronic myeloid leukemia study experience
Abstracts
442
DOCUMENTATION AND ANALYSIS OF A::RSE EVENT DATA IN CLINICAL THE GERMAN CHRONIC MYELOID LEUKEMIA STUDY EXPERIENCE Joerg Hasford, Hassan Ansarl, Dorothy Dlckson, Rudlger Hehlmann, the German CML Study Group Biometric Center for Therapeutic Studies Munchen, Germany
TRIALS:
and
The German Chronic Myeloid Leukemia Trial is a multicentre randomized trail to compare the treatment effects of busulfan vs hydroxyurea vs Interferon-alfa in patients with chronic phase CML. Six hudnred twentyfour (624) patients were randomoized from 66 centers. As only very limited experience with the treatment of CML-patients with IFN-alfa was available there was a strong emphasis on the observation and documentation of adverse events (AEs) under this treatment. The occurrence of AEs was routinely checked at standardized intervals. As the exisitng WHO Rating scale was limited an extended list of 41 symptoms was developed. One hundred sixty-four (164) patients randomly allocated to IFN-alfa are included in the analysis. The documentation of AEs increases the trial related paper work load of the physicians considerably. Thus continuous monitoring of protocol compliance and constant efforts to motivate the physicians are essential. It is important to assess a baseline of AEs prior to start of therapy. The major objectives of the analyses of AEs data are 1) to describe the type, severity, incidence and time of onset of AEs, 2) to extract risk factors for the occurrence of AEs, and 3) to assess the causality of AEs. It could be shown that the frequency of most AEs increases during the first two months of treatment, but approximates baseline rates thereafter. The analysis of the occurrence of AEs over time is essential as it allows insight into the mechanism of the AEs and assessment of the time-dependent risk for particular AEs. Finaly methods of analysis and presentation of AEs data, e.g., formal concept analysis, will be discussed.
442
DOCUMENTATION AND ANALYSIS OF A::RSE EVENT DATA IN CLINICAL THE GERMAN CHRONIC MYELOID LEUKEMIA STUDY EXPERIENCE Joerg Hasford, Hassan Ansarl, Dorothy Dlckson, Rudlger Hehlmann, the German CML Study Group Biometric Center for Therapeutic Studies Munchen, Germany
TRIALS:
and
The German Chronic Myeloid Leukemia Trial is a multicentre randomized trail to compare the treatment effects of busulfan vs hydroxyurea vs Interferon-alfa in patients with chronic phase CML. Six hudnred twentyfour (624) patients were randomoized from 66 centers. As only very limited experience with the treatment of CML-patients with IFN-alfa was available there was a strong emphasis on the observation and documentation of adverse events (AEs) under this treatment. The occurrence of AEs was routinely checked at standardized intervals. As the exisitng WHO Rating scale was limited an extended list of 41 symptoms was developed. One hundred sixty-four (164) patients randomly allocated to IFN-alfa are included in the analysis. The documentation of AEs increases the trial related paper work load of the physicians considerably. Thus continuous monitoring of protocol compliance and constant efforts to motivate the physicians are essential. It is important to assess a baseline of AEs prior to start of therapy. The major objectives of the analyses of AEs data are 1) to describe the type, severity, incidence and time of onset of AEs, 2) to extract risk factors for the occurrence of AEs, and 3) to assess the causality of AEs. It could be shown that the frequency of most AEs increases during the first two months of treatment, but approximates baseline rates thereafter. The analysis of the occurrence of AEs over time is essential as it allows insight into the mechanism of the AEs and assessment of the time-dependent risk for particular AEs. Finaly methods of analysis and presentation of AEs data, e.g., formal concept analysis, will be discussed.