SAFETY AND SYMPTOM IMPROVEMENT WITH ESOMEPRAZOLE IN ADOLESCENTS WITH GASTROESOPHAGEAL REFLUX DISEASE
Bibliographic record
Abstract
To assess the safety of esomeprazole and gastroesophageal reflux disease (GERD) symptom improvement in adolescents with clinically diagnosed GERD. In this multicenter, randomized, double-blind study (D9614C00098), boys and girls aged 12-17 y received treatment with esomeprazole 20 or 40 mg once daily for 8 weeks. Adverse events (AEs) and changes in physical examinations and laboratory measurements were assessed. Patients or their parents scored symptom severity as none (0), mild (1), moderate (2), or severe (3) based on the previous 72 hours at baseline and on the previous 24 hours during study treatment. Of 149 patients randomized, 60% were girls, mean BMI was 23.5 kg/m2, and 148 patients had postbaseline safety data. In each group, 11 patients had AEs judged by the investigator to be treatment-related; the most common were headache (8%), abdominal pain (3%), nausea (2%), and diarrhea (2%). No serious AEs, clinically important findings, trends in other safety assessments, or dose-related trends were reported or observed. At baseline, 68% had heartburn, 57% had acid regurgitation, 63% had epigastric pain,and 15% had vomiting. Mean (SD) patient diary symptom scores (final week scores were averaged over the final week)ast;<.0001 vs baseline (paired t-test). Both doses of esomeprazole significantly reduced the symptoms of heartburn, acid regurgitation, and epigastric pain and were well tolerated. Either 20 or 40 mg of esomeprazole reduces GERD-related symptoms in adolescents with clinically diagnosed GERD. The safety profile of esomeprazole in adolescents is similar to that observed in adults.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".