Comparative Safety Assessment Study for Drospirenone Induced Gallbladder Diseases Using the Adverse Drug Reaction Database of USA, Europe, and Canada
Bibliographic record
Abstract
BACKGROUND: Gallstone disease (GSD) is one of the most common gastroenterological disorders. It is known that drospirenone causes small increased risk of gallbladder diseases. However, the risk may vary between different adverse drug reaction databases. OBJECTIVE: The purpose of this studty is to examine the safety and risk association between hormonal contraceptive drospirenone and gallbladder diseases using adverse drug reaction database of USFDA's Federal Adverse Events Reporting System (FAERS), Europe's Eudravigilance (EV) and Canada's Canada Vigilance Adverse Reaction Online Database (CVARD). METHODS: Individual Case Safety Reports of patients till October 2019 were downloaded from the Federal Adverse Event Reporting System, Eudravigilance, and Canadian database. These reports contained information on adverse events associated with all other drugs inclusive of drospirenone. The disproportionality method of data mining was used to calculate the risk association. RESULTS: The lower limit of 95% CI of PRR was 3.27, 3.47 and 3.76, PRR was 33.08, 41.35 and 115.42, ROR was 37.20, 44.61 and 127.19, Chi-square value was 126572.89, 110392.95 and 362.46, and IC-2SD value was 0.16, 0.17, and 1.21 for FAERS, EU, and CVARD respectively indicating a week signal. Also, all the calculated parameters were above the threshold value. CONCLUSION: From our study, it was clear that the risk between drospirenone and gallbladder diseases was very low among three databases. There was no harm in prescribing this drug for a contraceptive action.
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 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 | 0.007 | 0.022 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.004 | 0.006 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".