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 | |
ACUTE KIDNEY INJURY | 0 (0–0) 0 | 88 (86–89) 88 | 0 (0–0) 0 | 73 (64–82) 73 | 23 | 27 |
AGGRESSION | 0 (0–0) 0 | 78 (67–89) 89 | 0 (0–0) 0 | 82 (82–91) 91 | 22 | 15 |
AMNESIA | 0 (0–0) 0 | 80 (79–89) 80 | 0 (0–0) 0 | 91 (82–91) 91 | 20 | 7 |
ANGINA PECTORIS | 0 (0–50) 0 | 90 (88–100) 100 | 0 (0–100) 0 | 82 (73–91) 82 | 33 | 16 |
ANGIOEDEMA | 0 (0–0) 0 | 86 (83–88) 83 | 0 (0–0) 0 | 55 (45–64) 55 | 45 | 45 |
ARRHYTHMIA | 0 (0–0) 0 | 90 (89–90) 90 | 0 (0–0) 0 | 82 (82–91) 91 | 41 | 13 |
BACTERIAL INFECTION | 75 (31–100) 100 | 80 (78–90) 80 | 33 (20–33) 33 | 91 (82–91) 91 | 3 | 11 |
BLINDNESS | 0 (0–0) 0 | 80 (75–80) 80 | 0 (0–0) 0 | 91 (82–91) 91 | 8 | 11 |
BRADYCARDIA | 0 (0–0) 0 | 90 (89–90) 90 | 0 (0–0) 0 | 91 (82–91) 91 | 32 | 11 |
CANDIDA INFECTION | 0 (0–0) 0 | 90 (82–90) 90 | 0 (0–0) 0 | 91 (91–91) 91 | 8 | 5 |
CARDIAC ARREST | 0 (0–0) 0 | 90 (78–90) 90 | 0 (0–0) 0 | 91 (82–91) 91 | 21 | 9 |
CARDIAC FAILURE | 0 (0–33) 0 | 89 (88–90) 100 | 0 (0–67) 0 | 73 (64–82) 73 | 40 | 25 |
CATARACT | 0 (0–0) 0 | 78 (70–80) 78 | 0 (0–0) 0 | 91 (82–91) 91 | 16 | 11 |
CELLULITIS | 0 (0–0) 0 | 90 (89–90) 90 | 0 (0–0) 0 | 91 (82–91) 91 | 12 | 9 |
CEREBROVASCULAR ACCIDENT | 0 (0–33) 0 | 89 (88–100) 89 | 0 (0–100) 0 | 80 (73–82) 82 | 35 | 22 |
CONJUNCTIVITIS | 0 (0–0) 0 | 80 (70–80) 80 | 0 (0–0) 0 | 82 (82–91) 91 | 29 | 13 |
DEAFNESS | 0 (0–0) 0 | 80 (70–80) 80 | 0 (0–0) 0 | 91 (82–91) 91 | 15 | 7 |
DELIRIUM | 0 (0–0) 0 | 75 (70–80) 76 | 0 (0–0) 0 | 82 (82–91) 91 | 14 | 13 |
DELUSION | 0 (0–0) 0 | 80 (72–80) 80 | 0 (0–0) 0 | 91 (91–91) 91 | 13 | 4 |
DISORIENTATION | 0 (0–0) 0 | 80 (80–85) 80 | 0 (0–0) 0 | 91 (91–91) 91 | 14 | 5 |
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS | 0 (0–0) 0 | 80 (78–89) 78 | 0 (0–0) 0 | 91 (82–91) 91 | 4 | 11 |
DYSGEUSIA | 0 (0–0) 0 | 89 (86–90) 89 | 0 (0–0) 0 | 80 (73–89) 82 | 31 | 20 |
ELECTROCARDIOGRAM QT PROLONGED | 0 (0–0) 0 | 89 (89–90) 90 | 0 (0–0) 0 | 82 (80–91) 82 | 20 | 15 |
EMBOLISM | 0 (0–0) 0 | 90 (90–90) 90 | 0 (0–0) 0 | 91 (90–91) 91 | 6 | 5 |
EOSINOPHILIA | 0 (0–0) 0 | 90 (89–90) 90 | 0 (0–0) 0 | 91 (82–91) 91 | 24 | 9 |
ERYTHEMA MULTIFORME | 0 (0–0) 0 | 80 (78–80) 80 | 0 (0–0) 0 | 91 (82–91) 91 | 25 | 9 |
FALL | 0 (0–0) 0 | 78 (67–89) 90 | 0 (0–0) 0 | 82 (82–91) 91 | 0 | 13 |
FRACTURE | 0 (0–0) 0 | 90 (90–90) 90 | 0 (0–0) 0 | 91 (90–91) 91 | 7 | 5 |
FUNGAL INFECTION | 100 (50–100) 100 | 80 (78–89) 80 | 33 (22–50) 33 | 91 (82–91) 91 | 6 | 9 |
GLAUCOMA | 0 (0–0) 0 | 80 (80–90) 80 | 0 (0–0) 0 | 91 (91–91) 91 | 14 | 5 |
HAEMATOMA | 0 (0–0) 0 | 89 (88–89) 89 | 0 (0–0) 0 | 82 (73–82) 82 | 16 | 20 |
HAEMOLYTIC ANAEMIA | 0 (0–0) 0 | 90 (90–90) 90 | 0 (0–0) 0 | 91 (91–91) 91 | 15 | 4 |
HAEMORRHAGE | 17 (0–33) 0 | 86 (75–88) 100 | 33 (0–50) 0 | 64 (56–73) 60 | 44 | 36 |
HALLUCINATION | 0 (0–0) 0 | 89 (89–90) 90 | 0 (0–0) 0 | 82 (80–91) 91 | 33 | 15 |
HEPATITIS | 0 (0–25) 0 | 88 (83–90) 89 | 0 (0–50) 0 | 78 (70–82) 80 | 43 | 24 |
HOSTILITY | 0 (0–0) 0 | 80 (78–88) 80 | 0 (0–0) 0 | 91 (82–91) 91 | 16 | 9 |
MEMORY IMPAIRMENT | 0 (0–0) 0 | 79 (70–80) 80 | 0 (0–0) 0 | 82 (82–91) 91 | 11 | 15 |
MYOSITIS | 0 (0–0) 0 | 80 (80–90) 80 | 0 (0–0) 0 | 91 (91–91) 91 | 5 | 4 |
PARALYSIS | 0 (0–0) 0 | 80 (78–90) 80 | 0 (0–0) 0 | 91 (82–91) 91 | 10 | 7 |
PARANOIA | 0 (0–0) 0 | 80 (80–90) 85 | 0 (0–0) 0 | 91 (91–91) 91 | 11 | 4 |
PHOTOSENSITIVITY REACTION | 0 (0–0) 0 | 90 (90–90) 90 | 0 (0–0) 0 | 91 (90–91) 91 | 34 | 5 |
RECTAL HAEMORRHAGE | 0 (0–0) 0 | 80 (80–90) 90 | 0 (0–0) 0 | 91 (91–91) 91 | 15 | 5 |
RESPIRATORY FAILURE | 0 (0–0) 0 | 89 (89–90) 90 | 0 (0–0) 0 | 82 (80–91) 91 | 16 | 15 |
RHABDOMYOLYSIS | 0 (0–0) 0 | 89 (80–90) 90 | 0 (0–0) 0 | 91 (82–91) 91 | 19 | 11 |
SLEEP DISORDER | 0 (0–0) 0 | 80 (80–90) 80 | 0 (0–0) 0 | 91 (91–91) 91 | 13 | 4 |
SUDDEN DEATH | 0 (0–0) 0 | 80 (70–80) 80 | 0 (0–0) 0 | 91 (91–91) 91 | 14 | 4 |
THROMBOPHLEBITIS | 0 (0–0) 0 | 90 (90–90) 90 | 0 (0–0) 0 | 91 (91–91) 91 | 12 | 4 |
TINNITUS | 0 (0–0) 0 | 89 (89–90) 90 | 0 (0–0) 0 | 82 (80–91) 91 | 41 | 15 |
TOXIC EPIDERMAL NECROLYSIS | 0 (0–50) 0 | 90 (89–100) 100 | 0 (0–100) 0 | 84 (80–91) 91 | 25 | 15 |
URTICARIA | 25 (0–40) 0 | 88 (80–90) 100 | 50 (0–75) 0 | 70 (60–80) 70 | 64 | 33 |
VAGINAL HAEMORRHAGE | 0 (0–0) 0 | 90 (90–90) 90 | 0 (0–0) 0 | 91 (91–91) 91 | 9 | 4 |
VASCULITIS | 0 (0–0) 0 | 90 (90–90) 90 | 0 (0–0) 0 | 91 (90–91) 91 | 15 | 5 |
VENTRICULAR ARRHYTHMIA | 0 (0–0) 0 | 88 (74–90) 90 | 0 (0–0) 0 | 91 (82–91) 91 | 29 | 7 |
VISION BLURRED | 0 (0–0) 0 | 88 (83–89) 89 | 0 (0–0) 0 | 82 (73–82) 82 | 0 | 22 |
VISUAL IMPAIRMENT | 33 (0–50) 0 | 90 (89–100) 100 | 50 (0–100) 0 | 89 (80–91) 91 | 38 | 15 |
WEIGHT INCREASED | 0 (0–0) 0 | 79 (70–88) 90 | 0 (0–0) 0 | 82 (73–91) 82 | 43 | 18 |