From: Predicting potential adverse events using safety data from marketed drugs
Adverse Event | Median (25th – 75th quantile) Mode | Prevalence (%) | ||||
---|---|---|---|---|---|---|
Sensitivity | Specificity | Positive Predictive Value | Negative Predictive Value | Comparator Drugs | Test Drugs | |
AGRANULOCYTOSIS | 50 (50–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (82–91) 91 | 23 | 11 |
ANAEMIA | 25 (17–33) 20 | 100 (100–100) 100 | 100 (100–100) 100 | 55 (45–64) 55 | 45 | 42 |
ANAPHYLACTIC REACTION | 25 (20–33) 25 | 100 (100–100) 100 | 100 (100–100) 100 | 64 (56–73) 73 | 37 | 35 |
BONE MARROW FAILURE | 100 (0–100) 100 | 100 (90–100) 100 | 100 (0–100) 100 | 91 (91–91) 91 | 14 | 5 |
BRONCHITIS | 33 (25–50) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 82 (73–90) 82 | 27 | 20 |
CEREBRAL HAEMORRHAGE | 33 (0–50) 0 | 100 (90–100) 100 | 100 (0–100) 100 | 82 (82–91) 91 | 14 | 15 |
CHOLESTASIS | 50 (50–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (82–91) 91 | 8 | 9 |
CONFUSIONAL STATE | 25 (20–33) 25 | 100 (100–100) 100 | 100 (100–100) 100 | 70 (60–80) 73 | 50 | 33 |
DEEP VEIN THROMBOSIS | 50 (33–100) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 90 (82–91) 91 | 11 | 13 |
DIABETES MELLITUS | 50 (0–100) 0 | 90 (90–100) 100 | 50 (0–100) 100 | 91 (82–91) 91 | 27 | 9 |
DIPLOPIA | 100 (100–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (91–100) 91 | 17 | 4 |
EXTRAPYRAMIDAL DISORDER | 100 (100–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (91–91) 91 | 21 | 4 |
FEBRILE NEUTROPENIA | 50 (33–100) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 90 (82–91) 91 | 7 | 15 |
GASTROINTESTINAL HAEMORRHAGE | 33 (25–50) 25 | 100 (100–100) 100 | 100 (100–100) 100 | 73 (64–82) 73 | 27 | 31 |
HEPATIC FAILURE | 33 (25–50) 33 | 100 (100–100) 100 | 100 (100–100) 100 | 73 (64–82) 73 | 29 | 25 |
HEPATOTOXICITY | 25 (0–33) 0 | 90 (88–100) 100 | 50 (0–100) 100 | 73 (67–82) 73 | 25 | 27 |
HYPERCHOLESTEROLAEMIA | 33 (0–50) 0 | 90 (89–100) 100 | 50 (0–100) 100 | 82 (80–91) 91 | 22 | 15 |
HYPERGLYCAEMIA | 25 (17–40) 0 | 100 (89–100) 100 | 100 (50–100) 100 | 78 (67–82) 80 | 36 | 27 |
HYPERKINESIA | 50 (50–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 90 (82–91) 91 | 36 | 13 |
HYPERSENSITIVITY | 20 (14–29) 17 | 100 (80–100) 100 | 100 (50–100) 100 | 44 (33–56) 50 | 67 | 58 |
HYPERTENSION | 50 (33–67) 50 | 100 (86–100) 100 | 100 (67–100) 100 | 75 (62–83) 67 | 57 | 40 |
HYPOGLYCAEMIA | 50 (25–100) 50 | 100 (90–100) 100 | 100 (50–100) 100 | 90 (82–91) 91 | 27 | 15 |
IMPAIRED HEALING | 100 (50–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (90–91) 91 | 2 | 7 |
INFECTION | 50 (33–67) 50 | 89 (86–100) 100 | 67 (50–100) 100 | 80 (73–89) 100 | 43 | 27 |
INSOMNIA | 20 (14–25) 17 | 100 (100–100) 100 | 100 (100–100) 100 | 55 (45–64) 55 | 58 | 49 |
INTERSTITIAL LUNG DISEASE | 50 (33–67) 50 | 100 (89–100) 100 | 100 (50–100) 100 | 89 (80–91) 90 | 12 | 18 |
JAUNDICE | 33 (0–50) 0 | 90 (89–100) 100 | 50 (0–100) 100 | 82 (80–91) 91 | 40 | 15 |
LARYNGEAL OEDEMA | 100 (67–100) 100 | 88 (79–100) 100 | 50 (33–100) 100 | 91 (82–91) 91 | 8 | 7 |
LEUKOPENIA | 25 (25–33) 25 | 100 (100–100) 100 | 100 (100–100) 100 | 73 (64–82) 73 | 44 | 29 |
MYOCARDIAL INFARCTION | 25 (0–40) 0 | 100 (88–100) 100 | 100 (0–100) 100 | 73 (67–82) 80 | 44 | 29 |
NEUROLEPTIC MALIGNANT SYNDROME | 100 (100–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (91–100) 91 | 16 | 4 |
NEUROPATHY PERIPHERAL | 40 (25–50) 50 | 86 (80–100) 100 | 67 (50–100) 100 | 67 (56–78) 67 | 60 | 42 |
NEUTROPENIA | 50 (33–60) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 75 (67–82) 78 | 23 | 38 |
OEDEMA | 20 (14–33) 0 | 83 (75–100) 100 | 67 (50–100) 100 | 44 (33–55) 50 | 71 | 58 |
PANCREATITIS | 50 (25–60) 50 | 90 (86–100) 100 | 75 (50–100) 100 | 80 (70–89) 78 | 33 | 29 |
PANCYTOPENIA | 50 (25–67) 50 | 100 (90–100) 100 | 100 (50–100) 100 | 90 (82–91) 91 | 21 | 15 |
PNEUMONIA | 50 (25–67) 50 | 89 (86–100) 100 | 50 (33–100) 100 | 86 (78–90) 100 | 37 | 22 |
PROTEINURIA | 50 (33–50) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 89 (82–91) 91 | 12 | 15 |
PULMONARY EMBOLISM | 50 (25–100) 50 | 100 (90–100) 100 | 100 (50–100) 100 | 90 (82–91) 91 | 18 | 13 |
PULMONARY OEDEMA | 50 (0–100) 0 | 90 (90–100) 100 | 50 (0–100) 100 | 90 (82–91) 91 | 17 | 9 |
RENAL FAILURE | 50 (33–67) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 89 (80–91) 91 | 28 | 18 |
RENAL IMPAIRMENT | 50 (33–100) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (82–91) 91 | 27 | 11 |
SEIZURE | 33 (0–50) 0 | 89 (86–100) 100 | 50 (0–100) 100 | 78 (70–88) 80 | 49 | 27 |
SEPSIS | 50 (33–67) 50 | 100 (100–100) 100 | 100 (100–100) 100 | 88 (78–90) 100 | 20 | 24 |
SEROTONIN SYNDROME | 100 (50–100) 100 | 100 (100–100) 100 | 100 (100–100) 100 | 91 (91–100) 100 | 13 | 7 |
STEVENS-JOHNSON SYNDROME | 33 (20–50) 33 | 100 (90–100) 100 | 100 (50–100) 100 | 80 (73–89) 82 | 28 | 24 |
STOMATITIS | 33 (0–50) 0 | 89 (86–100) 100 | 50 (0–100) 100 | 82 (75–90) 80 | 28 | 22 |
SUICIDAL BEHAVIOUR | 25 (20–33) 33 | 100 (100–100) 100 | 100 (100–100) 100 | 82 (73–82) 82 | 24 | 22 |
SUPRAVENTRICULAR TACHYCARDIA | 33 (25–50) 33 | 100 (100–100) 100 | 100 (100–100) 100 | 80 (73–90) 82 | 27 | 24 |
TACHYCARDIA | 40 (25–50) 50 | 90 (86–100) 100 | 75 (50–100) 100 | 78 (67–88) 78 | 61 | 31 |
THROMBOCYTOPENIA | 40 (25–50) 50 | 88 (83–100) 100 | 67 (50–100) 100 | 73 (62–80) 67 | 58 | 36 |
UPPER RESPIRATORY TRACT INFECTION | 20 (17–33) 20 | 100 (86–100) 100 | 100 (50–100) 100 | 60 (50–70) 60 | 28 | 44 |
URINARY TRACT INFECTION | 25 (20–40) 25 | 100 (88–100) 100 | 100 (67–100) 100 | 67 (56–75) 70 | 32 | 40 |