Trial · NCT01724021
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6 | Cycle 6 (Up to 24 weeks) | ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8 | Cycle 8 (Up to 32 weeks) | ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) | Randomization of first participant to clinical cutoff date (Up to 4 years) | The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | participants | NUMBER |
| SECONDARY | Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV]) | Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks) | ITT population included all participants who were randomized in the study. | minutes | MEDIAN |
| SECONDARY | Cancer Therapy Satisfaction Questionnaire (CTSQ) Score | During Cycle 4, 8 of treatment (Up to 32 weeks) | ITT population included all participants who were randomized in the study. Here, Number Analyzed represents the number of participants who were evaluable at specified time points. | units on a scale | MEAN |
| SECONDARY | Rituximab Administration Satisfaction Questionnaire (RASQ) Score | During Cycle 4, 8 of treatment (Up to 32 weeks) | ITT population included all participants who were randomized in the study. Here, Number Analyzed represents the number of participants who were evaluable at specified time points. | units on a scale | MEAN |
| SECONDARY | Complete Response (CR) Rate | 28 days (± 3 days) after Day 1 of the last dose of induction treatment | ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) | ITT population included all participants who were randomized in the study. | months | MEDIAN |
| SECONDARY | Disease-free Survival (DFS) | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) | ITT population included all participants who were randomized in the study. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) | ITT population included all participants who were randomized in the study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years) | ITT population included all participants who were randomized in the study. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Anti-Rituximab Antibodies Over Time | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) | The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) | The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Summary of Observed Serum Rituximab Concentration | Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years) | The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points. | microgram per milliter | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01724021/outcomes