P-137 Safety of Adalimumab in Global Clinical Trials of Ulcerative Colitis Patients
Bibliographic record
Abstract
The safety profile of adalimumab (ADA) has been previously reported for the double-blind (DB) pivotal trials ULTRA 1 and ULTRA 2 in patients (pts) with moderate to severe ulcerative colitis (UC).1,2 Safety data from the ongoing open-label extension (OLE) continue to be collected. All patients participating in ULTRA 1, ULTRA 2, and OLE had regular safety evaluations. Rates of adverse events (AEs) of interest were assessed per 100 patient-years (PY) of exposure. Event rates were calculated for placebo (PBO) and ADA during the DB period (up to week 52) from ULTRA 1 (160/80 mg dose group only) and ULTRA 2 and through 15 April 2012 for any ADA exposure (ULTRA 1, ULTRA 2, or the OLE). As of 15 Apr 2012, 1010 pts had received ADA for UC, totaling 2007.4 PY of exposure. AE rates observed during DB treatment and up to the 15 April 2012 update are shown (Table). A similar overall rate of AEs was observed during DB treatment between PBO and ADA. Serious AEs, serious infections, AEs leading to discontinuation, and UC worsening/flare were more frequent with PBO, whereas opportunistic infections, injection site reactions, and hepatic events were more frequent with ADA. AE rates during any ADA exposure were consistent with rates previously reported for ADA and other anti-TNFs in CD.3,4 The safety profile and AE rates observed with long-term ADA exposure (up to 4 yrs) in UC were similar to those occurring during DB therapy. No new safety signals were identified. References: 1. Reinisch, et al. 2011. Gut;60:780. 2. Sandborn, et al. 2012. Gastroenterology;142:257. 3. Colombel, et al. 2009. Inflamm Bowel Dis;5:1308. 4. Lichtenstein, et al. 2012. Am J Gastroenterol;107:1409.
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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 | 0.010 | 0.012 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".