P735 Incidence of venous thromboembolic complications in controlled trials of inflammatory bowel disease
Bibliographic record
Abstract
Patients with inflammatory bowel disease (IBD) have an increased risk of venous thromboembolic (VTE) complications compared with the general population. Incidences of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients with IBD are reported as 30.0–31.4/10 000 person-years (p-y) and 10.3–19.8/10 000 p-y, respectively.1 To date, no study in patients with moderate-to-severe IBD has examined incidence of VTE complications in a controlled clinical setting. We aimed to evaluate the incidence of thromboembolic events across five clinical trials of an anti-MAdCAM monoclonal antibody (SHP647) in patients with IBD. Data were pooled from five clinical trials of SHP647 in patients with Crohn’s disease (CD) and ulcerative colitis (UC) (NCT01276509; NCT01298492; NCT01387594; NCT01620255; NCT01771809). Three were 12-week induction studies, and two were open-label extension studies lasting 18–36 months. One study (NCT01771809) is ongoing. Patients had moderate-to-severe disease (CD: CDAI 220–450; UC: total Mayo score > 6). All adverse events were collected and coded using the Medical Dictionary for Regulatory Activities (MedDRA) system. The safety database was searched using Standardised MedDRA Query terms of: Embolic and Thrombotic events; Arterial, Embolic and Thrombotic events; and Venous and Ischaemic Central Nervous System Vascular Conditions. Person-years of exposure were calculated to include a 6-month post-treatment follow-up period, owing to the long half-life of the drug (5–9 days). In total, 668 patients were enrolled across the five clinical trials (CD, n = 311; UC, n = 357). Placebo exposure was 35.4 p-y, while drug exposure was 1005.1 p-y. There were 17 thromboembolic events reported overall: 5 arterial and 12 venous. One event (PE in a 26-year-old woman treated with SHP647 225 mg) was fatal. The incidences of DVT and PE are presented in Table 1. The incidence of VTE appeared higher for CD than UC (risk ratio [95% CI] of events/p-y of exposure: 2.4 [0.88, 6.65]). Incidence of thromboembolic events in patients with UC and CD. *A total of 126 patients who received placebo also received SHP647 in the extension studies, and are included in both groups. ^Includes thrombotic events other than DVT and PE. The overall incidences of DVT and PE in these five trials of SHP647 were within the range reported for the overall IBD population, when considering the wide-ranging confidence intervals. The total numbers of events in the UC, CD and placebo groups were small and insufficient for robust conclusions on relative rates. 1. Bernstein, The incidence of deep venous thrombosis and pulmonary embolism among patients with inflammatory bowel disease: a population-based cohort study. J Thromb Haemost, 2001;85:430–4.
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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 | 0.029 | 0.089 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.005 |
| Bibliometrics | 0.003 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.017 | 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".