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. 2020 Dec 18;2020(12):CD008500. doi: 10.1002/14651858.CD008500.pub5

Vadhan‐Raj 2013.

Study characteristics
Methods Trial acronym: none reported, registry Identifier of NCI CTRP: NCI‐2011‐01773
Design: randomised, open‐label, parallel‐group trial
Median duration of follow‐up: not reported
Participants Patients aged ≥ 18 years with a diagnosis of advanced stage (unresectable or metastatic) adenocarcinoma of the pancreas planning to initiate systemic chemotherapy within 2 weeks, ECOG performance status 0–2, adequate renal function (creatinine clearance > 50 mL/minute).
Mean age: 52 (range 36–77) years overall; 59 (range 36–75) years in dalteparin group; 64 (range 38–77) years in control group
Gender, n (%) males: 41 (54.7%) males overall; 20 (52.6%) in dalteparin group; 21 (56.8%) in control group
Metastatic disease: not reported
Previous VTE: not reported
Interventions Intervention: LMWH, dalteparin (5000 IU SC, once daily) for 16 weeks during chemotherapy
Control: chemotherapy alone
Outcomes Primary outcome: venous thromboembolic events during 16 weeks of treatment
Other outcomes mentioned in the abstract: adverse events, clinically significant bleeding, overall survival
Notes Funding: not reported; however, Eisai Inc. is listed as collaborator at ClinicalTrials.gov
Disclosure of potential conflicts of interest: not reported
Publication format: published conference abstract
Baseline characteristics and overall VTE outcome data available at clinicaltrials.gov/ct2/show/results/NCT00966277. The trial database was used as source for data extraction.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "were randomized 1:1 to dalteparin vs control arms."
Comment: method of sequence generation not reported.
Allocation concealment (selection bias) Unclear risk Quote: "were randomized 1:1 to dalteparin vs control arms."
Comment: method of allocation concealment not reported.
Blinding (performance bias and detection bias)
All outcomes High risk Comment: open‐label study. It is not reported in the abstract if outcome assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "All 75 patients were evaluable for response in an intent‐to‐treat analysis."
Comment: all randomised participants were included in the analysis.
Selective reporting (reporting bias) Unclear risk Comment: study not published as full report yet. The conference abstract did not address all planned outcomes in sufficient detail.