Table 4.

Episodes of grade 3 and 4 toxicities on CCG-1891

DIDIVPIDDI
No. episodesEpisodes per 100 patient days4-150No. episodesEpisodes per 100 patient days4-150No. episodesEpisodes per 100 patient days4-150
Hepatic       
 SGOT 69 0.023 71 0.025 59 0.020 
 SGPT 205 0.068 213 0.074 240 0.083 
 Alkaline phosphatase 0.003 16 0.006 0.002 
 Bilirubin 33 0.011 35 0.012 27 0.009 
Pancreatic 0.0 0.001 0.003 
Renal 0.001 0.0 0.001 
Gastrointestinal 11 0.004 10 0.004 24 0.008 
Pulmonary 0.002 0.003 10 0.003 
Cardiac 0.0 0.0 0.001  
Nervous system       
 Peripheral 0.001 0.003 0.002 
 Central 0.0 0.001 0.001 
Dermatological 0.003 12 0.004 12 0.004 
Blood coagulation 0.0 0.001 16 0.006 
Infection 21 0.007 20 0.007 46 0.016 
DIDIVPIDDI
No. episodesEpisodes per 100 patient days4-150No. episodesEpisodes per 100 patient days4-150No. episodesEpisodes per 100 patient days4-150
Hepatic       
 SGOT 69 0.023 71 0.025 59 0.020 
 SGPT 205 0.068 213 0.074 240 0.083 
 Alkaline phosphatase 0.003 16 0.006 0.002 
 Bilirubin 33 0.011 35 0.012 27 0.009 
Pancreatic 0.0 0.001 0.003 
Renal 0.001 0.0 0.001 
Gastrointestinal 11 0.004 10 0.004 24 0.008 
Pulmonary 0.002 0.003 10 0.003 
Cardiac 0.0 0.0 0.001  
Nervous system       
 Peripheral 0.001 0.003 0.002 
 Central 0.0 0.001 0.001 
Dermatological 0.003 12 0.004 12 0.004 
Blood coagulation 0.0 0.001 16 0.006 
Infection 21 0.007 20 0.007 46 0.016 

Data shown are frequencies of grade 3 or 4 nonhematological toxicities, enumerated from the beginning of the second interim maintenance (DDI) or maintenance (DI and DIVPI).

SGOT indicates serum glutamic-oxaloacetic transaminase; SGPT, serum glutamic-pyruvic transaminase. See Table 1 footnote for other abbreviations.

F4-150

Patient days were defined as the total number of days spent on therapy for all patients entering interim maintenance 2 (DDI) or maintenance (DI and DIVPI). Episodes per 100 patient days were calculated as number of episodes per total patient days divided by 100.

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