Table 6.
The top signal strength of AEs of Alprazolam ranked by EBGM at the PTs level.
| SOC | PTs | Case reports | ROR (95% CI) | PRR (95% CI) | χ2 | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|---|
| Investigations | Benzodiazepine drug level abnormal | 7 | 447.58 (170.36–1175.89) | 447.54 (170.36–1175.72) | 1834.59 | 2.96 (1.73) | 263.67 (100.36) |
| Blood and lymphatic system disorders | Acquired amegakaryocytic thrombocytopenia | 6 | 182.68 (73.73–452.64) | 182.67 (73.73–452.58) | 843.15 | 2.75 (1.53) | 142.30 (57.43) |
| Pregnancy, puerperium and perinatal conditions | Postnatal growth restriction | 4 | 182.68 (60.13–555.00) | 182.67 (60.13–554.95) | 562.10 | 2.28 (0.83) | 142.30 (46.84) |
| Social circumstances | Prescription form tampering | 122 | 161.08 (132.06–196.47) | 160.82 (131.88–196.12) | 15,482.91 | 5.98 (5.69) | 128.70 (105.51) |
| Cardiac disorders | Papillary muscle disorder | 4 | 159.84 (53.44–478.14) | 159.84 (53.44–478.09) | 505.095 | 2.28 (0.84) | 128.07 (42.81) |
| Social circumstances | Victim of chemical submission | 46 | 140.80 (102.31–193.76) | 140.72 (102.27–193.62) | 5230.19 | 5.07 (4.61) | 115.51 (83.94) |
| Investigations | Postmortem blood drug level abnormal | 19 | 135.01 (82.30–221.45) | 134.97 (82.29–221.38) | 2086.20 | 4.09 (3.39) | 111.62 (68.05) |
| Blood and lymphatic system disorders | Cutaneous T-cell dyscrasia | 4 | 116.25 (40.06–337.36) | 116.24 (40.06–337.32) | 386.70 | 2.26 (0.86) | 98.51 (33.95) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sarcomatoid carcinoma | 6 | 109.61 (46.10–260.60) | 109.60 (46.10–260.57) | 551.18 | 2.72 (1.54) | 93.71 (39.41) |
| Nervous system disorders | Peripheral nerve paresis | 6 | 103.69 (43.76–245.67) | 103.68 (43.76–245.64) | 524.99 | 2.71 (1.54) | 89.35 (37.71) |
| Psychiatric disorders | Withdrawal catatonia | 15 | 95.92 (55.74–165.05) | 95.90 (55.74–165.00) | 1224.94 | 3.76 (2.99) | 83.52 (48.54) |
| Immune system disorders | Anamnestic reaction | 6 | 93.57 (39.72–220.40) | 93.56 (39.72–220.37) | 479.30 | 2.70 (1.54) | 81.75 (34.70) |
| Endocrine disorders | Pseudophaeochromocytoma | 7 | 91.34 (41.37–201.67) | 91.33 (41.37–201.64) | 547.24 | 2.88 (1.79) | 80.04 (36.25) |
| Cardiac disorders | Coronary no-reflow phenomenon | 3 | 87.19 (26.09–291.30) | 87.18 (26.09–291.28) | 224.91 | 1.94 (0.39) | 76.84 (23.00) |
| Psychiatric disorders | Paramnesia | 8 | 85.25 (40.77–178.29) | 85.25 (40.77–178.26) | 587.70 | 3.02 (2.00) | 75.33 (36.02) |
| Social circumstances | Chemical submission | 15 | 84.88 (49.53–145.47) | 84.87 (49.53–145.43) | 1097.52 | 3.74 (2.97) | 75.04 (43.79) |
| Social circumstances | Substance abuser | 9 | 68.51 (34.45–136.24) | 68.50 (34.45–136.22) | 540.71 | 3.12 (2.16) | 61.97 (31.16) |
| Psychiatric disorders | Sopor | 1065 | 64.03 (60.10–68.22) | 63.16 (59.33–67.24) | 59,311.78 | 5.77 (5.68) | 57.57 (54.04) |
| Nervous system disorders | Adrenergic syndrome | 5 | 58.13 (23.27–145.21) | 58.12 (23.27–145.19) | 257.31 | 2.45 (1.22) | 53.36 (21.36) |
| Nervous system disorders | Glossopharyngeal nerve disorder | 3 | 58.12 (17.83–189.53) | 58.12 (17.83–189.51) | 154.38 | 1.92 (0.40) | 53.36 (16.37) |
| Injury, poisoning and procedural complications | Poisoning deliberate | 463 | 54.86 (49.88–60.33) | 54.53 (49.61–59.95) | 22,422.49 | 5.51 (5.37) | 50.33 (45.76) |
| Surgical and medical procedures | Drug withdrawal maintenance therapy | 4 | 48.25 (17.46–133.33) | 48.25 (17.46–133.32) | 172.10 | 2.20 (0.85) | 44.94 (16.26) |
| Investigations | Coma scale | 4 | 44.87 (16.28–123.66) | 44.87 (16.28–123.65) | 160.30 | 2.19 (0.85) | 41.99 (15.24) |
| Respiratory, thoracic and mediastinal disorders | Pneumonitis aspiration | 12 | 44.10 (24.57–79.16) | 44.09 (24.57–79.14) | 472.78 | 3.33 (2.50) | 41.31 (23.01) |
| Investigations | Benzodiazepine drug level increased | 5 | 43.79 (17.70–108.37) | 43.79 (17.70–108.36) | 195.67 | 2.42 (1.20) | 41.05 (16.59) |
| Psychiatric disorders | Drug use disorder | 256 | 43.56 (38.37–49.44) | 43.41 (38.26–49.26) | 9934.24 | 5.14 (4.95) | 40.72 (35.87) |
| Social circumstances | Immobilisation prolonged | 6 | 41.70 (18.26–95.24) | 41.70 (18.26–95.22) | 223.73 | 2.60 (1.47) | 39.20 (17.17) |
| Psychiatric disorders | Mixed anxiety and depressive disorder | 11 | 40.66 (22.10–74.79) | 40.65 (22.10–74.77) | 400.01 | 3.22 (2.36) | 38.28 (20.81) |
| Respiratory, thoracic and mediastinal disorders | Bradypnoea | 108 | 39.15 (32.24–47.55) | 39.10 (32.20–47.48) | 3778.54 | 4.79 (4.51) | 36.90 (30.38) |
| Injury, poisoning and procedural complications | Oesophagitis chemical | 3 | 38.36 (11.97–123.00) | 38.36 (11.97–122.99) | 102.98 | 1.88 (0.39) | 36.25 (11.30) |