Metadata record for the article: NRG Oncology/NSABP B-47 Menstrual History Study: Impact of Adjuvant Chemotherapy with and without Trastuzumab
Bibliographic record
Abstract
This metadata record provides details of the data supporting the claims of the related article: “NRG Oncology/NSABP B-47 Menstrual History Study: Impact of Adjuvant Chemotherapy with and without Trastuzumab.”The aims of the related study were to assemble an observational cohort of pre/perimenopausal women to evaluate the effect of trastuzumab on treatment-related amenorrhea (TRA) and the associations between TRA and circulating reproductive hormone levels. This data record is associated with an article, which is a secondary publication from the main trial. The primary publication of the main trial is https://doi.org/10.1200/JCO.19.01455.<br><br>Type of data: clinical data; multi-center randomized trial of chemotherapy with and without trastuzumab.Subject of data: Women with an intact uterus; at least one ovary; at least one menstrual period in the past 12 months; no use of current oral contraceptive hormones or other hormone replacement therapy.Sample size: 1,458 women enrolled in this study of whom 1,231 consented to baseline blood samples.Population characteristics: Mean age of participants was 44.1 years. 81.5% were White, 90.5% were Non-hispanic, and 86.1% were estrogen-receptor and/or progesterone-receptor positive.Recruitment: Eligible women were enrolled in the B-47 MH substudy upon random assignment to the parent trial.Date of data collection: Participants enrolled from February 8, 2011 to February 10, 2015; Menstrual history assessed through 36 months of follow-up. Geographic location: Multi-center trial in USA, Canada, and Ireland.Trial registration number: https://clinicaltrials.gov/ct2/show/NCT01275677<br><b>Data access</b>The data generated in this study are gathered in csv format with file name B47MHSubstudy.csv.This data file will be available from the NCTN/NCORP Data Archive repository one year after publication of the related article. This in accordance with the policy of the National Cancer Institute (https://nctn-data-archive.nci.nih.gov/).<br>After the embargo period the data file will be made available to researchers who wish to analyze the data in secondary studies to enhance the public health benefit of the original work. Data access requirements may include (but not be limited to): a research plan and a Data Use Agreement (DUA), with legally binding signatures.<br><b>Corresponding author(s) for this study</b><br>Reena Cecchini (CecchiniR@nrgoncology.org)Patricia Ganz (PGanz@mednet.ucla.edu)<br><b>Study approval</b> This multi-center trial was approved by the National Cancer Institute's Central Institutional Review Board (CIRB) and/or local human investigations committees or institutional review boards at institutions participating in this multi-center trial in accordance with National Cancer Institute policies and procedures, with assurances filed with and approved by the Department of Health and Human Services. Written informed consent was required for participation.<br>
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.235 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".