Trial · NCT00878709
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| PRIMARY | Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Randomization until death due to any cause (up to 119 Months) | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| SECONDARY | Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| SECONDARY | Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 | From randomization until time of event up to 2 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| OTHER_PRE_SPECIFIED | Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 5 by Treatment Arms | From randomization until time of event up to 5 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| OTHER_PRE_SPECIFIED | Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 5 | From randomization until time of event up to 5 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | percentage of participants with events | NUMBER |
| OTHER_PRE_SPECIFIED | Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 5 | From randomization until time of event up to 5 years | Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment. | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00878709/outcomes