Heart Protection Study (HPS)

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 Active simvastatin Placebo simvastatin Risk ratio (95% CI) Absolute excess (SE)
expander Any event 6924 (67.4%) 7273 (70.8%) 0.90 (0.88- 0.94) -3.41% ( 0.64%)
expander Blood and lymphatic system disorders 108 ( 1.1%) 102 ( 1.0%) 1.05 (0.80- 1.38) 0.06% ( 0.14%)
expander Cardiac disorders 2080 (20.3%) 2533 (24.7%) 0.80 (0.75- 0.84) -4.42% ( 0.58%)
expander Congenital, familial and genetic disorders 9 ( 0.1%) 5 ( 0.0%) 1.74 (0.61- 4.96) 0.04% ( 0.04%)
expander Ear and labyrinth disorders 17 ( 0.2%) 19 ( 0.2%) 0.89 (0.46- 1.70) -0.02% ( 0.06%)
expander Endocrine disorders 43 ( 0.4%) 25 ( 0.2%) 1.68 (1.05- 2.71) 0.18% ( 0.08%)
expander Eye disorders 106 ( 1.0%) 98 ( 1.0%) 1.07 (0.82- 1.41) 0.08% ( 0.14%)
expander Gastrointestinal disorders 610 ( 5.9%) 647 ( 6.3%) 0.93 (0.84- 1.04) -0.36% ( 0.33%)
expander General disorders and administration site conditions 449 ( 4.4%) 474 ( 4.6%) 0.94 (0.83- 1.07) -0.24% ( 0.29%)
expander Hepatobiliary disorders 118 ( 1.1%) 102 ( 1.0%) 1.15 (0.88- 1.50) 0.16% ( 0.14%)
expander Immune system disorders 17 ( 0.2%) 16 ( 0.2%) 1.05 (0.53- 2.09) 0.01% ( 0.06%)
expander Infections and infestations 963 ( 9.4%) 1037 (10.1%) 0.92 (0.84- 1.00) -0.72% ( 0.41%)
expander Injury, poisoning and procedural complications 583 ( 5.7%) 668 ( 6.5%) 0.86 (0.77- 0.96) -0.83% ( 0.33%)
expander Investigations 1559 (15.2%) 1692 (16.5%) 0.91 (0.85- 0.97) -1.30% ( 0.51%)
expander Metabolism and nutrition disorders 400 ( 3.9%) 405 ( 3.9%) 0.98 (0.85- 1.12) -0.05% ( 0.27%)
expander Musculoskeletal and connective tissue disorders 175 ( 1.7%) 190 ( 1.9%) 0.91 (0.74- 1.12) -0.15% ( 0.18%)
expander Neoplasms benign, malignant and unspecified (incl cysts and polyps) 1134 (11.0%) 1093 (10.6%) 1.03 (0.95- 1.12) 0.40% ( 0.43%)
expander Nervous system disorders 920 ( 9.0%) 1090 (10.6%) 0.83 (0.76- 0.91) -1.66% ( 0.41%)
expander Psychiatric disorders 75 ( 0.7%) 75 ( 0.7%) 0.99 (0.72- 1.36) -0.00% ( 0.12%)
expander Renal and urinary disorders 263 ( 2.6%) 235 ( 2.3%) 1.11 (0.93- 1.32) 0.27% ( 0.21%)
expander Reproductive system and breast disorders 61 ( 0.6%) 50 ( 0.5%) 1.21 (0.83- 1.76) 0.11% ( 0.10%)
expander Respiratory, thoracic and mediastinal disorders 401 ( 3.9%) 446 ( 4.3%) 0.89 (0.78- 1.02) -0.44% ( 0.28%)
expander Skin and subcutaneous tissue disorders 119 ( 1.2%) 111 ( 1.1%) 1.06 (0.82- 1.38) 0.08% ( 0.15%)
expander Social circumstances 3 ( 0.0%) 1 ( 0.0%) 2.71 (0.38- 19.26) 0.02% ( 0.02%)
expander Surgical and medical procedures 3468 (33.8%) 3676 (35.8%) 0.92 (0.88- 0.96) -2.03% ( 0.66%)
expander Vascular disorders 325 ( 3.2%) 357 ( 3.5%) 0.90 (0.77- 1.05) -0.31% ( 0.25%)
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 7126 (69.4%) 7071 (68.9%) 1.02 (0.99- 1.05) 0.52% ( 0.64%)
expander Blood and lymphatic system disorders 88 ( 0.9%) 122 ( 1.2%) 0.72 (0.55- 0.95) -0.33% ( 0.14%)
expander Cardiac disorders 2331 (22.7%) 2282 (22.2%) 1.02 (0.97- 1.08) 0.47% ( 0.58%)
expander Congenital, familial and genetic disorders 7 ( 0.1%) 7 ( 0.1%) 0.99 (0.35- 2.84) -0.00% ( 0.04%)
expander Ear and labyrinth disorders 23 ( 0.2%) 13 ( 0.1%) 1.75 (0.91- 3.36) 0.10% ( 0.06%)
expander Endocrine disorders 32 ( 0.3%) 36 ( 0.4%) 0.89 (0.55- 1.43) -0.04% ( 0.08%)
expander Eye disorders 99 ( 1.0%) 105 ( 1.0%) 0.94 (0.72- 1.24) -0.06% ( 0.14%)
expander Gastrointestinal disorders 641 ( 6.2%) 616 ( 6.0%) 1.04 (0.93- 1.16) 0.24% ( 0.33%)
expander General disorders and administration site conditions 453 ( 4.4%) 470 ( 4.6%) 0.97 (0.85- 1.10) -0.17% ( 0.29%)
expander Hepatobiliary disorders 109 ( 1.1%) 111 ( 1.1%) 0.98 (0.76- 1.28) -0.02% ( 0.14%)
expander Immune system disorders 20 ( 0.2%) 13 ( 0.1%) 1.53 (0.77- 3.03) 0.07% ( 0.06%)
expander Infections and infestations 986 ( 9.6%) 1014 ( 9.9%) 0.97 (0.89- 1.06) -0.27% ( 0.41%)
expander Injury, poisoning and procedural complications 651 ( 6.3%) 600 ( 5.8%) 1.09 (0.98- 1.22) 0.50% ( 0.33%)
expander Investigations 1629 (15.9%) 1622 (15.8%) 1.01 (0.94- 1.08) 0.07% ( 0.51%)