Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Analysis population is modified intent to treat (MITT), comprising 626 randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from analyses.

Reporting Groups

	Description
PegIntron	PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control	No text entered.

Participant Flow:   Overall Study

	PegIntron	Untreated Control
STARTED	311	315
COMPLETED	195	197
NOT COMPLETED	116	118
Adverse Event	53	12
Withdrawal by Subject	34	54
Lost to Follow-up	5	5
Protocol-defined Clinical Event	17	32
Noncompliance With Protocol	4	12
Did Not Meet Protocol Eligibility	2	2
Administrative	1	1

Reporting Groups

	Description
PegIntron	PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control	No text entered.

Baseline Measures

	PegIntron	Untreated Control	Total
Number of Participants   [units: participants]	311	315	626
Age, Customized   [units: Participants]
<=50 years	130	132	262
>50 years	181	183	364
Gender   [units: Participants]
Female	105	100	205
Male	206	215	421

1.  Primary:

Time to Observation of the First Clinical Event Experienced by a Subject   [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]

2.  Secondary:

Time to Observation of the Disease Progression Experienced by a Subject   [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]