Molecular Therapy

TABLE 3

FROM:

Phase I Trial of Replication-competent Adenovirus-mediated Suicide Gene Therapy Combined with IMRT for Prostate Cancer

Svend O Freytag, Benjamin Movsas, Ibrahim Aref, Hans Stricker, James Peabody, Jan Pegg, Yingshu Zhang, Kenneth N Barton, Stephen L Brown, Mei Lu, Adnan Savera and Jae Ho Kim

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Table 3. Comparison of adverse events in Office of Biotechnology Activities protocols 0307-590 and 0104-464

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Likely attribution ofadverse eventProtocol 0307-590 (Ad5-yCD/mutTKSR39 rep-ADP)Protocol 0104-464 (Ad5-CD/TKrep)
 Grade (% of patients)Grade (% of patients)
 1234Total1234Total
Adenoviral therapy
 SGOT/SGPT44   44337  40
Prodrug therapy
 Anemia3311  4467   67
 Leukopenia3311  445313  67
 Lymphopenia115622 89 8013 93
 Neutropenia22   2220   20
 Thrombocytopenia11   1127   27
Radiation therapy 
 RTOG gastrointestinal3333  672727  54
 RTOG genitourinary2244  6767277 100
 Fatigue11   11407  47
Unknown
 Hyperglycemia  1111227337 47

  Abbreviations: RTOG, Radiation Therapy Oncology Group; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamic pyruvic transaminase.

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