Table 3 Example format Summary of safety aspects of clinical trials of [insert name of the substance under evaluation] – Type of study Subject details Treatment details Adverse reactions Endpoints Key outcomes (reference) (dose, duration, and safety indicators route) Randomised, placebo 56 patients, 5 mg per day PO for 8 No differences between At least two plasma cholesterol and controlled double blind weeks after 6 weeks of test and placebo for lipid (overnight fast), LDL cholesterol mean age 60 years: 7 dietary stabilisation bwt, heart rate, systolic blood biochemistry decreased significantly (Cunningham male; 49 female. et al. & diastolic bp, ALT, measurements & (p<0.001) in the 2001) Hypercholesterolaemic glucose, creatinine clinical examination at (substance) treatment 15-day intervals group by 15 per cent 8 Adverse reaction weeks after the start of reports: cephalea treatment. Difference (1/27), insomnia between groups also (1/27), muscle cramps significant (p<0.001). (1/27) There were no significant changes in HDL cholesterol, plasma triglycerides, or VLDL cholesterol levels compared with the placebo values. Table 4. Example format Summary of adverse drug reactions for [insert name of the substance under evaluation] – Report Patient details Product details Treatment Other Adverse Comments (e.g. Causality reference and details medicines reaction outcome; date reported laboratory results)
Table 3 Example format – Summary of safety aspects of clinical trials of [insert name of the substance under evaluation] Type of study (reference) Subject details Treatment details (dose, duration, route) Adverse reactions and safety indicators Endpoints Key outcomes Randomised, placebo controlled double blind (Cunningham et al. 2001) 56 patients, mean age 60 years: 7 male; 49 female. Hypercholesterolaemic 5 mg per day PO for 8 weeks after 6 weeks of dietary stabilisation No differences between test and placebo for bwt, heart rate, systolic & diastolic bp, ALT, glucose, creatinine Adverse reaction reports: cephalea (1/27), insomnia (1/27), muscle cramps (1/27) At least two plasma lipid (overnight fast), blood biochemistry measurements & clinical examination at 15-day intervals cholesterol and LDL cholesterol decreased significantly (p<0.001) in the (substance) treatment group by 15 per cent 8 weeks after the start of treatment. Difference between groups also significant (p<0.001). There were no significant changes in HDL cholesterol, plasma triglycerides, or VLDL cholesterol levels compared with the placebo values. Table 4. Example format – Summary of adverse drug reactions for [insert name of the substance under evaluation] Report reference and date reported Patient details Product details Treatment details Other medicines Adverse reaction Comments (e.g. outcome; laboratory results) Causality