| Primary | Treatment Failure - Percentage of Participants With an Event | Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment. | | Posted | | Number | | percentage of participants | | Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Primary | Treatment Failure - Time to Event | The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates. | | Posted | | Median | 95% Confidence Interval | months | | BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR) | CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes greater than (>) 1 centimeter (cm) or nodes >1.5 cm observed in computerized axial tomography (CAT) scan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate. PR was defined as a decrease of greater than or equal to (≥) 50 percent (%) compared with the BL value in the sum of the products of the two largest perpendicular diameters in all measurable and evaluable lesions; and a ≥50% reduction of the size from BL if hepato-splenomegaly was present. | ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 10 and 16 | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Percentage of Participants Achieving CR or CRu | CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes >1 cm or nodes >1.5 cm observed in CATscan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate. | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 10 and 16 | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Duration of Response - Percentage of Participants With an Event | Response duration was defined as the period between the date for first observation of CR, CRu or PR and the date of progressive disease (PD), censored observation or death of any cause. Response duration was also assessed for response defined as CR only. Response duration was calculated among responders (CR+CRu+PR) with cutoffs for follow-up applied. | | Posted | | Number | | percentage of participants | | BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Duration of Response | The median time, in months, from the date of the first observation of CR, CRu, or PR and the date of progressive disease (PD), censored observation, or death due to any cause. PD was defined as an increase of >50% compared to BL in the sum of the product of the two largest perpendicular parameters of measurable lymphoma, or the occurrence of new lesions. One month=30.4 days. Response duration was calculated amongst responders (CR+CRu+PR) with cutoffs for follow-up applied. | ITT population; n=number of participants assessed for the specified parameter at a given visit. Only participants with a response (CR+CRu+PR, CR+CRu, or CR only) were included in the analysis. | Posted | | Median | 95% Confidence Interval | months | | BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Disease Progression - Percentage of Participants With an Event | A disease progression event was defined as tumor progression or death due to any cause (or a censored observation). | | Posted | | Number | | percentage of participants | | BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Time to Disease Progression | The median time, in months, from randomization to disease progression event assessed using Kaplan-Meier estimates. One month=30.4 days | | Posted | | Median | 95% Confidence Interval | months | | BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | An overall survival event was defined as death due to any cause. | | Posted | | Number | | percentage of participants | | BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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| Secondary | Overall Survival | The median time, in months, from randomization to OS event assessed using Kaplan-Meier estimates. One month=30.4 days | | Posted | | Median | Full Range | months | | BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period | | | | ID | Title | Description |
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| OG000 | Rituximab Monotherapy | Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles. | | OG001 | Rituximab + IFN | Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles. |
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