Table 4.
The important medical events (IMEs) of SARS-CoV-2 neutralizing monoclonal antibodies identified as signal in each system organ class (SOC) from the FAERS database
| SOC | IME | Primary suspected cases, n | ROR (95%, CI) | IC (95% lower limit) | Drug label (FDA) |
|---|---|---|---|---|---|
| Bamlanivimab | |||||
| Respiratory, thoracic and mediastinal disorders | Hypoxia | 309 | 39.06 (34.83 ~ 43.79) | 5.13 (4.58) | Y |
| COVID-19 pneumonia | 256 | 34.04 (30.04 ~ 38.59) | 4.94 (4.36) | N | |
| Pneumonia | 177 | 2.32 (2.00 ~ 2.69) | 1.20 (1.03) | Y | |
| Vascular disorders | Syncope | 53 | 2.65 (2.03 ~ 3.48) | 1.38 (1.05) | Y |
| Pulmonary embolism | 45 | 2.80 (2.09 ~ 3.75) | 1.45 (1.08) | Y | |
| Anaphylactic reaction | 40 | 3.53 (2.58 ~ 4.81) | 1.77 (1.30) | Y | |
| Cardiac disorders | Atrial fibrillation | 81 | 3.56 (2.86 ~ 4.43) | 1.80 (1.45) | Y |
| Bradycardia | 58 | 5.14 (3.97 ~ 6.66) | 2.30 (1.78) | Y | |
| Pulseless electrical activity | 5 | 4.95 (2.06 ~ 11.92) | 1.86 (0.77) | N | |
| Casirivimab/Imdevimab | |||||
| Respiratory, thoracic and mediastinal disorders | Hypoxia | 236 | 29.75 (26.12 ~ 33.89) | 4.76 (4.18) | Y |
| COVID-19 pneumonia | 142 | 18.69 (15.82 ~ 22.08) | 4.11 (3.48) | Y | |
| Acute respiratory failure | 87 | 19.68 (15.91 ~ 24.34) | 4.12 (3.34) | N | |
| Vascular disorders | Anaphylactic reaction | 95 | 8.52 (6.96 ~ 10.44) | 3.02 (2.47) | Y |
| Syncope | 88 | 4.47 (3.62 ~ 5.51) | 2.12 (1.72) | N | |
| Distributive shock | 6 | 12.46 (5.57 ~ 27.86) | 2.72 (1.22) | N | |
| Nervous system disorders | Loss of consciousness | 73 | 3.05 (2.43 ~ 3.85) | 1.58 (1.26) | N |
| Unresponsive to stimuli | 55 | 12.84 (9.84 ~ 16.75) | 3.51 (2.70) | N | |
| Encephalopathy | 14 | 2.94 (1.74 ~ 4.98) | 1.46 (0.86) | N | |
| Bamlanivimab/Etesevimab | |||||
| Respiratory, thoracic and mediastinal disorders | Hypoxia | 62 | 40.47 (31.44 ~ 52.09) | 4.91 (3.82) | Y |
| COVID-19 pneumonia | 39 | 26.71 (19.46 ~ 36.66) | 4.31 (3.14) | N | |
| Acute respiratory failure | 30 | 35.35 (24.64 ~ 50.70) | 4.48 (3.13) | N | |
| Vascular disorders | Anaphylactic reaction | 25 | 11.72 (7.90 ~ 17.38) | 3.26 (2.20) | Y |
| Syncope | 17 | 4.51 (2.80 ~ 7.27) | 2.03 (1.26) | Y | |
| Pulmonary embolism | 11 | 3.61 (2.00 ~ 6.53) | 1.69 (0.94) | N | |
| Metabolism and nutrition disorders | Diabetic ketoacidosis | 8 | 9.03 (4.51 ~ 18.09) | 2.61 (1.30) | Y |
| Hypokalemia | 6 | 3.16 (1.42 ~ 7.05) | 1.44 (0.65) | N | |
| Type 2 diabetes mellitus | 3 | 2.63 (0.85 ~ 8.16) | 1.09 (0.35) | N | |
| Sotrovimab | |||||
| Respiratory, thoracic and mediastinal disorders | COVID19-pneumonia | 50 | 22.20 (16.79 ~ 29.36) | 4.17 (3.16) | Y |
| Hypoxia | 46 | 19.23 (14.38 ~ 25.74) | 3.99 (2.98) | Y | |
| Respiratory failure | 22 | 5.43 (3.57 ~ 8.26)) | 2.29 (1.51) | Y | |
| Vascular disorders | Anaphylactic reaction | 42 | 12.81 (9.45 ~ 17.36) | 3.48 (2.56) | Y |
| Anaphylactoid reaction | 6 | 35.84 (16.03 ~ 80.10) | 3.28 (1.47) | N | |
| Acute myocardial infarction | 5 | 4.10 (1.71 ~ 9.87) | 1.67 (0.70) | N | |
| Cardiac disorders | Bradycardia | 25 | 7.61 (5.13 ~ 11.28) | 2.74 (1.85) | Y |
| Atrial fibrillation | 22 | 3.31 (2.18 ~ 5.04) | 1.65 (1.09) | Y | |
| Cardiac arrest | 14 | 3.63 (2.15 ~ 6.14) | 1.73 (1.02) | N | |
| Bebtelovimab | |||||
| Respiratory, thoracic and mediastinal disorders | Hypoxia | 13 | 17.93 (10.38 ~ 30.97) | 3.45 (2.00) | Y |
| Respiratory distress | 11 | 24.39 (13.47 ~ 44.17) | 3.45 (2.00) | N | |
| Respiratory arrest | 4 | 7.64 (5.10 ~ 36.35) | 2.50 (0.94) | N | |
| Vascular disorders | Anaphylactic reaction | 32 | 9.23 (6.52 ~ 13.07) | 3.02 (2.14) | Y |
| Syncope | 20 | 3.26 (2.10 ~ 5.06) | 1.62 (1.05) | Y | |
| Pulmonary embolism | 3 | 2.11 (0.68 ~ 6.56) | 0.87 (0.28) | N | |
| Nervous system disorders | Unresponsive to stimuli | 23 | 17.25 (11.44 ~ 26.00) | 3.67 (2.43) | N |
| Loss of consciousness | 18 | 2.42 (1.53 ~ 3.85) | 1.22 (0.77) | N | |
| Seizure | 14 | 4.97 (2.94 ~ 8.42) | 2.12 (1.25) | N | |
| Tixagevimab/Cilgavimab | |||||
| Respiratory, thoracic and mediastinal disorders | COVID19-pneumonia | 11 | 6.70 (3.70 ~ 12.11) | 2.42 (1.34) | N |
| Hypoxia | 9 | 5.16 (2.68 ~ 9.94) | 2.08 (1.08) | Y | |
| pulmonary edema | 6 | 3.08 (1.38 ~ 6.86) | 1.41 (0.63) | N | |
| Vascular disorders | Anaphylactic reaction | 19 | 8.00 (5.09 ~ 12.56) | 2.75 (1.75) | Y |
| Deep vein thrombosis | 14 | 7.29 (4.31 ~ 12.33) | 2.58 (1.52) | N | |
| Pulmonary embolism | 12 | 3.55 (2.01 ~ 6.26) | 1.68 (0.96) | N | |
| Cardiac disorders | Atrial fibrillation | 25 | 5.24 (3.54 ~ 7.77) | 2.27 (1.53) | Y |
| Cardiac arrest | 18 | 6.50 (4.09 ~ 10.33) | 2.49 (1.57) | Y | |
| Bradycardia | 8 | 3.36 (1.68 ~ 6.73) | 1.56 (0.78) | N | |