Trial · NCT01358877
Outcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (including SPNBC) at 3 years. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DFS event at 3 years. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died, First Interim Overall Survival Analysis | Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died, Final Overall Survival Analysis | Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years | 3 years | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for death at Year 3. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for death at at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | ITT population. Overall number of participants analyzed=participants remaining at risk for RFI event at 3 years. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DRFI event at 3 years. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Primary Cardiac Event, Primary Analysis | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) | Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Primary Cardiac Event, Final Analysis | Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years) | Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Secondary Cardiac Event, Primary Analysis | Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years) | Safety population | percentage of participants | NUMBER |
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.
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