Study of the Effectiveness of Additional Reductions of Cholesterol and Homocysteine (SEARCH)

Serious adverse events by MedDRA classification

These results are organised hierarchically by MedDRA SOC, HLGT and HLT categories. To expand a row to show the next level of the hierarchy, click the + symbol; to contract it, click the - symbol.

Simvastatin comparison: Fatal or non-fatal serious adverse events in all patients
MedDRA term Simvastatin 80mg Simvastatin 20mg Risk ratio (95% CI) Absolute excess (SE)
expander Any event 5023 (83.3%) 5039 (83.5%) 1.00 (0.96- 1.04) -0.24% ( 0.68%)
expander Blood and lymphatic system disorders 116 ( 1.9%) 121 ( 2.0%) 0.96 (0.74- 1.24) -0.08% ( 0.25%)
expander Cardiac disorders 1722 (28.6%) 1747 (29.0%) 0.98 (0.92- 1.05) -0.40% ( 0.82%)
expander Congenital, familial and genetic disorders 2 ( 0.0%) 4 ( 0.1%) 0.51 (0.10- 2.55) -0.03% ( 0.04%)
expander Ear and labyrinth disorders 41 ( 0.7%) 43 ( 0.7%) 0.95 (0.62- 1.46) -0.03% ( 0.15%)
expander Endocrine disorders 77 ( 1.3%) 92 ( 1.5%) 0.84 (0.62- 1.13) -0.25% ( 0.21%)
expander Eye disorders 127 ( 2.1%) 133 ( 2.2%) 0.95 (0.75- 1.22) -0.10% ( 0.26%)
expander Gastrointestinal disorders 510 ( 8.5%) 567 ( 9.4%) 0.89 (0.79- 1.01) -0.94% ( 0.52%)
expander General disorders and administration site conditions 484 ( 8.0%) 450 ( 7.5%) 1.08 (0.95- 1.23) 0.57% ( 0.49%)
expander Hepatobiliary disorders 107 ( 1.8%) 95 ( 1.6%) 1.13 (0.85- 1.48) 0.20% ( 0.23%)
expander Immune system disorders 20 ( 0.3%) 20 ( 0.3%) 1.00 (0.54- 1.86) 0.00% ( 0.10%)
expander Infections and infestations 850 (14.1%) 866 (14.4%) 0.98 (0.89- 1.08) -0.26% ( 0.64%)
expander Injury, poisoning and procedural complications 688 (11.4%) 705 (11.7%) 0.98 (0.88- 1.08) -0.28% ( 0.58%)
expander Investigations 1753 (29.1%) 1782 (29.5%) 0.98 (0.92- 1.05) -0.47% ( 0.83%)
expander Metabolism and nutrition disorders 732 (12.1%) 674 (11.2%) 1.09 (0.98- 1.21) 0.97% ( 0.58%)
expander Musculoskeletal and connective tissue disorders 427 ( 7.1%) 379 ( 6.3%) 1.13 (0.99- 1.30) 0.80% ( 0.45%)
expander Neoplasms benign, malignant and unspecified (incl cysts and polyps) 855 (14.2%) 924 (15.3%) 0.92 (0.84- 1.01) -1.14% ( 0.65%)
expander Nervous system disorders 669 (11.1%) 693 (11.5%) 0.96 (0.87- 1.07) -0.39% ( 0.58%)
expander Psychiatric disorders 76 ( 1.3%) 80 ( 1.3%) 0.95 (0.69- 1.30) -0.07% ( 0.21%)
expander Renal and urinary disorders 156 ( 2.6%) 184 ( 3.0%) 0.85 (0.68- 1.05) -0.46% ( 0.30%)
expander Reproductive system and breast disorders 61 ( 1.0%) 60 ( 1.0%) 1.02 (0.71- 1.45) 0.02% ( 0.18%)
expander Respiratory, thoracic and mediastinal disorders 496 ( 8.2%) 412 ( 6.8%) 1.21 (1.06- 1.38) 1.40% ( 0.48%)
expander Skin and subcutaneous tissue disorders 201 ( 3.3%) 199 ( 3.3%) 1.01 (0.83- 1.23) 0.03% ( 0.33%)
expander Social circumstances 3 ( 0.0%) 6 ( 0.1%) 0.51 (0.14- 1.90) -0.05% ( 0.05%)
expander Surgical and medical procedures 2558 (42.4%) 2557 (42.4%) 0.99 (0.94- 1.05) 0.03% ( 0.90%)
expander Vascular disorders 261 ( 4.3%) 314 ( 5.2%) 0.83 (0.70- 0.98) -0.88% ( 0.39%)
Vitamin comparison: Fatal or non-fatal serious adverse events in all patients
MedDRA term Active vitamins Placebo vitamins Risk ratio (95% CI) Absolute excess (SE)
expander Any event 5066 (84.0%) 4996 (82.8%) 1.03 (0.99- 1.07) 1.13% ( 0.68%)
expander Blood and lymphatic system disorders 105 ( 1.7%) 132 ( 2.2%) 0.80 (0.62- 1.03) -0.45% ( 0.25%)
expander Cardiac disorders 1775 (29.4%) 1694 (28.1%) 1.06 (0.99- 1.13) 1.33% ( 0.82%)
expander Congenital, familial and genetic disorders 2 ( 0.0%) 4 ( 0.1%) 0.51 (0.10- 2.55) -0.03% ( 0.04%)
expander Ear and labyrinth disorders 47 ( 0.8%) 37 ( 0.6%) 1.27 (0.83- 1.95) 0.17% ( 0.15%)
expander Endocrine disorders 83 ( 1.4%) 86 ( 1.4%) 0.97 (0.72- 1.31) -0.05% ( 0.21%)
expander Eye disorders 133 ( 2.2%) 127 ( 2.1%) 1.05 (0.82- 1.34) 0.10% ( 0.26%)
expander Gastrointestinal disorders 552 ( 9.1%) 525 ( 8.7%) 1.06 (0.94- 1.20) 0.44% ( 0.52%)
expander General disorders and administration site conditions 464 ( 7.7%) 470 ( 7.8%) 0.99 (0.87- 1.12) -0.10% ( 0.49%)
expander Hepatobiliary disorders 106 ( 1.8%) 96 ( 1.6%) 1.11 (0.84- 1.46) 0.17% ( 0.23%)
expander Immune system disorders 16 ( 0.3%) 24 ( 0.4%) 0.67 (0.36- 1.25) -0.13% ( 0.10%)
expander Infections and infestations 848 (14.1%) 868 (14.4%) 0.98 (0.89- 1.07) -0.34% ( 0.64%)
expander Injury, poisoning and procedural complications 708 (11.7%) 685 (11.4%) 1.04 (0.93- 1.15) 0.38% ( 0.58%)
expander Investigations 1808 (30.0%) 1727 (28.6%) 1.06 (1.00- 1.14) 1.33% ( 0.83%)
expander Metabolism and nutrition disorders 718 (11.9%) 688 (11.4%) 1.05 (0.94- 1.16) 0.49% ( 0.58%)
expander Musculoskeletal and connective tissue disorders 416 ( 6.9%) 390 ( 6.5%) 1.07 (0.93- 1.23) 0.43% ( 0.45%)
expander Neoplasms benign, malignant and unspecified (incl cysts and polyps) 904 (15.0%) 875 (14.5%) 1.04 (0.94- 1.14) 0.48% ( 0.65%)
expander Nervous system disorders 684 (11.3%) 678 (11.2%) 1.01 (0.91- 1.13) 0.10% ( 0.58%)
expander Psychiatric disorders 79 ( 1.3%) 77 ( 1.3%) 1.03 (0.75- 1.41) 0.03% ( 0.21%)
expander Renal and urinary disorders 186 ( 3.1%) 154 ( 2.6%) 1.21 (0.98- 1.50) 0.53% ( 0.30%)
expander Reproductive system and breast disorders 60 ( 1.0%) 61 ( 1.0%) 0.99 (0.69- 1.41) -0.02% ( 0.18%)
expander Respiratory, thoracic and mediastinal disorders 461 ( 7.6%) 447 ( 7.4%) 1.04 (0.91- 1.18) 0.23% ( 0.48%)
expander Skin and subcutaneous tissue disorders 181 ( 3.0%) 219 ( 3.6%) 0.83 (0.68- 1.01) -0.63% ( 0.33%)
expander Social circumstances 6 ( 0.1%) 3 ( 0.0%) 1.95 (0.53- 7.21) 0.05% ( 0.05%)
expander Surgical and medical procedures 2582 (42.8%) 2533 (42.0%) 1.03 (0.97- 1.08) 0.80% ( 0.90%)
expander Vascular disorders 282 ( 4.7%) 293 ( 4.9%) 0.96 (0.82- 1.13) -0.18% ( 0.39%)

F Analysis only includes female subjects.

M Analysis only includes male subjects.

freezer 2016-04-27
Report date 2016-04-27