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. |