Risk of intracranial hypertension with intrauterine levonorgestrel
Bibliographic record
Abstract
OBJECTIVES: The objective of this study was to quantify the risk of intracranial hypertension (ICH) with the intrauterine levonorgestrel (IUL) device Mirena(®). METHODS: We used the United States Food and Drug Administration's Adverse Events Reporting System (FAERS) database to quantify a reporting odds ratio (ROR) for ICH and Mirena(®). We also conducted a retrospective cohort study using the IMS LifeLink(®) database, comparing the risk of two oral contraceptives ethinyl estradiol (EE) with Mirena(®). A Bayesian sensitivity analysis was performed to account for the effect of body mass index (BMI). RESULTS: The reported odds ratios (ORs) for ICH and papilledema with Mirena(®) were 1.78 (95% confidence interval [CI] 1.41-2.25) and 1.50 (95% CI 1.10-2.05), respectively. In the cohort study, the OR for ICH and EE-norgestimate and EE-norethindrone compared with Mirena(®) were 1.29 (95% CI 0.83-2.00) and 0.31 (95% CI 0.04-2.29), respectively. The presence of a strong confounder BMI did not affect the estimated OR (OR = 1.31, 95% CI 0.73-2.41 for EE-norgestimate; OR = 0.18, 95% CI 0.01-1.27 for EE-norethindrone). CONCLUSION: We found a higher than expected number of reports of ICH with Mirena(®) in the FAERS database. We also found a similar risk of ICH with Mirena(®) compared with the oral contraceptive EE-norgestimate. The higher risk of ICH with EE-norethindrone, another oral contraceptive should be further investigated.
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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) | 0.000 | 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 | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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".