Klerk 2005.
Study characteristics | ||
Methods | Trial acronym: MALT Design: multicentre, double‐blind, randomised, placebo‐controlled study with intention‐to‐treat analyses for both effectiveness and safety, including participants who received ≥ 1 study dose Mean duration of follow‐up: 12 months |
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Participants | Patients with metastasised or locally advanced solid tumours Median age: 63 (range 36–86) years in nadroparin group; 64 (range 28–83) years in placebo group Gender, n (%) males: 77 (52%) in nadroparin group; 81 (53%) in placebo group Metastatic disease, n (%): 137 (93%) in nadroparin group; 139 (90%) in placebo group Previous VTE: 0/302 (0%) overall |
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Interventions | Intervention: LMWH, nadroparin Control: placebo Prefilled syringes containing a fixed volume of nadroparin (9500 anti‐factor Xa U/mL) or placebo were provided according to participant’s weight: 0.4 mL for those weighing < 50 kg, 0.6 mL for those weighing 50–70 kg, and 0.8 mL for those weighing > 70 kg. Administered SC twice daily during the initial 14 days of treatment and once daily thereafter for another 4 weeks. |
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Outcomes | Primary efficacy outcome: death from any cause Primary safety outcome: major bleeding Secondary safety outcome: clinically relevant non‐major bleeding |
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Notes | Funding: treatment provided by Sanofi‐Synthelabo (Paris, France). The authors stated that "protocol design, data collection, and analysis were solely the responsibility of the authors." Disclosure of potential conflicts of interest: the senior author and statistician declared consultancy activities for various pharmaceutical companies, including Sanofi‐Synthelabo. Publication format: full‐text publication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Sequentially numbered boxes of syringes with nadroparin or placebo were prepared using a central computer‐generated randomization schedule, stratified for body weight with blocks of four." Comment: adequate method of sequence generation. |
Allocation concealment (selection bias) | Low risk | Quote: "Sequentially numbered boxes of syringes with nadroparin or placebo were prepared using a central computer‐generated randomization schedule, stratified for body weight with blocks of four." Comment: adequate method of allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Prefilled syringes containing a fixed volume of nadroparin (9,500 antifactor Xa U/mL) or placebo were provided according to patient’s weight." Comment: trial reported as double‐blind, with active substance or placebo provided in prefilled syringes. It was not reported whether syringes were identical in appearance or if outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all enrolled participants were included in the analysis. |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported in the methods section were addressed in the results or discussion section. The authors reported reasons for the discontinuation of the study drug in the results section only, but this was for descriptive purposes, so unlikely to introduce bias. |