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
 

 With NIPENT
 With IFN
 

 N=180
 N=176
 
Upper Respiratory Infection
 13
 8
 
Rhinitis
 11
 15
 
Herpes Zoster
 8
 1
 
Pharyngitis
 8
 11
 
Viral Infection
 8
 17
 
Infection (Unspecified)
 7
 2
 
Sinusitis
 6
 4
 
Cellulitis
 6
 3
 
Bacterial Infection
 5
 4
 
Pneumonia
 5
 7
 
Conjunctivitis
 4
 2
 
Furunculosis
 4
 <1
 
Herpes Simplex
 4
 1
 
Bronchitis
 3
 2
 
Sepsis
 3
 2
 
Urinary Tract Infection
 3
 3
 
Abscess, Skin
 2
 4
 
Moniliasis, Oral
 2
 <1
 
Mycotic Infection, Skin
 <1
 3
 
Osteomyelitis
 1
 0
The drug relatedness of the adverse events listed below cannot be excluded. The following adverse events occurred in 3% to 10% of NIPENT-treated patients in the initial phase of the SWOG study:

Body as a Whole—Chest Pain, Death, Face Edema, Peripheral Edema

Cardiovascular System—Hemorrhage, Hypotension

Digestive System&mdas