Treated
 Treated
 Treated With

 With Nipent
 With IFN
 Nipent

 N=180
 N=176
 N=197
Nausea and/or Vomiting
 63
 22
   53b
Fever
 46
 59
 42
Rash
 43
 30
 26
Fatigue
 42
 55
 29
Leukopenia
 22
 15
 60
Pruritus
 21
 6
 10
Coughing/Increased Cough
 20
 15
 17
Myalgia
 19
 36
 11
Chills
 19
 34
 11
Headache
 17
 29
 13
Diarrhea
 17
 17
 15
Abdominal Pain
 16
 15
 4
Anorexia
 13
 10
 16
Upper Respiratory Infection
 13
 8
 16
Asthenia
 12
 13
 10
Stomatitis
 12
 7
 5
Rhinitis
 11
 15
 10
Dyspnea
 11
 13
 8
Anemia
 8
 5
 35
Pain
 8
 19
 20
 
Pharyngitis
 8
 11
 10
Sweating/Increased Sweating
 8
 21
 10
Viral Infection
 8
 17
 NR
Infection
 7c
 2c
 36
Arthralgia
 6
 14
 3
Thrombocytopenia
 6
 6
 32
Skin Disorder
 4
 5
 17
Allergic Reaction
 2
 1
 11
Hepatic Disorder/Elevated Liver Function Testsd
 2
 2
 19
Neurologic Disorder, CNS/CNS Toxicity
 1
 NR
 11
Lung Disorder/Disease
 NR
 1
 12
Nausea
 NR
 NR
 22
Genitourinary Disorder
 NR
 NR
 15
NR = Not Reported

a Occurring in more than 10% of patients, in any group, regardless of drug association

b Includes only nausea with vomiting

c These figures represent only unspecified infections. Refer to infection table.

d Elevated liver enzymes and liver disorder for SWOG
The total incidence for all types of infections is considerably higher for both treatment groups in the SWOG 8691 study than is listed in the table above. An intent-to-treat analysis of infections found that 38% of patients treated with Nipent and 34% of patients treated with IFN averaged 2.4 and 1.9 documented infections during treatment, respectively. The following table lists the different types of infections that were reported as adverse events during the initial phase of the SWOG study. There were no apparent differences in the types of infection between the 2 treatment groups, with the possible exception of herpes zoster which was reported more frequently for Nipent (8%) than for IFN (1%).
Percent of Patients
Type of Infection
 Frontline, Treated
 Frontline, Treated