Table 3.
Signal strength of reports of Osimertinib at the Preferred Term (PT) level in FAERS database.
| SOC | Preferred terms (PTs) | Osimertinib cases reporting PT | ROR (95% two-sided CI) |
PRR (χ2) |
IC (IC 025) |
EBGM (EBGM 05) |
|---|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Myelosuppression | 79 | 15.53 (14.94–16.14) | 9.68 (34,904.03) | 3.26 (3.20) | 9.57 (9.21) |
| Cardiac disorders | Cardiac failure | 111 | 26.04 (23.54–28.82) | 25.11 (9007.09) | 4.52 (4.37) | 24.36 (22.01) |
| Pericardial effusion* | 40 | 15.18 (13.63–16.92) | 14.73 (4342.61) | 3.80 (3.64) | 14.47 (12.99) | |
| Cardiomyopathy* | 37 | 2.84 (2.54–3.16) | 2.78 (380.97) | 1.46 (1.30) | 2.77 (2.49) | |
| Cardiotoxicity | 26 | 7.54 (6.59–8.64) | 7.41 (1184.5) | 2.83 (2.63) | 7.35 (6.42) | |
| Cardiac dysfunction* | 19 | 254.76 (216.08–300.36) | 250.3 (35,659.35) | 6.57 (6.33) | 189.42 (160.66) | |
| Cardiac failure acute* | 18 | 12.97 (11.18–15.05) | 12.77 (1913.25) | 3.56 (3.34) | 12.58 (10.84) | |
| Long QT syndrome | 8 | 3.63 (3.13–4.22) | 3.59 (330.94) | 1.81 (1.59) | 3.58 (3.08) | |
| Ventricular dysfunction* | 6 | 6.73 (5.77–7.87) | 6.65 (777.17) | 2.67 (2.44) | 6.60 (5.65) | |
| Congenital, familial and genetic disorders | Acquired gene mutation* | 190 | 3.02 (2.58–3.54) | 2.99 (205.95) | 1.55 (1.32) | 2.99 (2.55) |
| EGFR gene mutation | 39 | 3.47 (2.92–4.11) | 3.44 (229.53) | 1.74 (1.49) | 3.43 (2.89) | |
| Gene mutation | 14 | 7.93 (6.65–9.46) | 7.85 (746.42) | 2.87 (2.61) | 7.78 (6.52) | |
| BRAF gene mutation* | 8 | 3.94 (3.30–4.71) | 3.91 (265.85) | 1.92 (1.65) | 3.90 (3.26) | |
| Eye disorders | Keratitis | 7 | 2.82 (2.34–3.40) | 2.80 (128.8) | 1.45 (1.17) | 2.80 (2.32) |
| Gastrointestinal disorders | Stomatitis | 123 | 2.97 (2.45–3.61) | 2.95 (134.22) | 1.52 (1.23) | 2.95 (2.43) |
| Volvulus* | 7 | 4.72 (3.85–5.79) | 4.69 (268.66) | 2.15 (1.85) | 4.67 (3.80) | |
| Mechanical ileus* | 4 | 37.55 (30.14–46.78) | 37.27 (2829.17) | 4.64 (4.32) | 35.6 (28.58) | |
| General disorders and administration site conditions | Death | 4,349 | 4.15 (3.33–5.16) | 4.12 (190.86) | 1.97 (1.64) | 4.11 (3.30) |
| Drug resistance | 401 | 10.49 (8.39–13.10) | 10.42 (664.14) | 3.19 (2.86) | 10.29 (8.24) | |
| Disease progression | 177 | 2.84 (2.26–3.59) | 2.83 (85.24) | 1.44 (1.10) | 2.83 (2.24) | |
| Hepatobiliary disorders | Hepatic function abnormal* | 126 | 17.93 (14.06–22.86) | 17.82 (1040.3) | 3.79 (3.43) | 17.44 (13.68) |
| Liver disorder* | 81 | 14.98 (11.57–19.4) | 14.91 (751.24) | 3.55 (3.17) | 14.64 (11.31) | |
| Infections and infestations | Paronychia | 84 | 3.33 (2.54–4.37) | 3.32 (85.69) | 1.64 (1.24) | 3.31 (2.53) |
| Pneumonia bacterial* | 20 | 6.15 (4.63–8.18) | 6.13 (204.53) | 2.43 (2.01) | 6.09 (4.58) | |
| Nail infection | 8 | 4.26 (3.17–5.71) | 4.24 (111) | 1.95 (1.52) | 4.22 (3.15) | |
| Infectious pleural effusion* | 6 | 5.59 (4.17–7.5) | 5.57 (167.81) | 2.30 (1.87) | 5.54 (4.13) | |
| Lymphangitis | 5 | 14.76 (10.91–19.97) | 14.71 (539.18) | 3.44 (2.99) | 14.45 (10.68) | |
| Injury, poisoning and procedural complications | Radiation pneumonitis* | 26 | 4.66 (3.43–6.34) | 4.65 (116.7) | 2.06 (1.6) | 4.62 (3.40) |
| Investigations | Platelet count decreased | 155 | 3.76 (2.75–5.13) | 3.75 (80.27) | 1.77 (1.31) | 3.73 (2.74) |
| Electrocardiogram QT prolonged | 93 | 3.30 (2.41–4.53) | 3.30 (62.19) | 1.60 (1.14) | 3.29 (2.40) | |
| Ejection fraction decreased | 48 | 155.48 (110.19–219.39) | 154.92 (4970.31) | 4.91 (4.41) | 129.27 (91.61) | |
| Blood creatine phosphokinase increased | 45 | 9.50 (6.9–13.09) | 9.47 (284.53) | 2.91 (2.44) | 9.37 (6.80) | |
| Carcinoembryonic antigen increased | 37 | 40.00 (28.73–55.68) | 39.86 (1333.32) | 4.23 (3.74) | 37.96 (27.26) | |
| Amylase increased* | 13 | 6.09 (4.40–8.42) | 6.07 (155.63) | 2.37 (1.90) | 6.03 (4.36) | |
| SARS-CoV-2 test negative | 12 | 2.82 (2.03–3.91) | 2.81 (42.00) | 1.38 (0.90) | 2.81 (2.02) | |
| Tumour marker increased | 11 | 5.94 (4.03–8.73) | 5.92 (105.64) | 2.26 (1.69) | 5.89 (4.00) | |
| BRAF V600E mutation positive* | 6 | 18.92 (12.82–27.93) | 18.88 (429.72) | 3.43 (2.86) | 18.45 (12.50) | |
| Myocardial necrosis marker increased* | 5 | 4.73 (3.05–7.35) | 4.73 (58.42) | 1.93 (1.28) | 4.70 (3.03) | |
| Metabolism and nutrition disorders | Decreased appetite | 332 | 9.17 (5.83–14.42) | 9.16 (136.50) | 2.62 (1.95) | 9.06 (5.76) |
| Hypophagia | 36 | 5.38 (3.38–8.56) | 5.38 (63.68) | 2.04 (1.36) | 5.34 (3.36) | |
| Musculoskeletal and connective tissue disorders | Immobilisation syndrome* | 4 | 6.82 (4.29–10.86) | 6.81 (88.55) | 2.30 (1.61) | 6.76 (4.25) |
| Nervous system disorders | Taste disorder | 41 | 5.77 (3.63–9.17) | 5.76 (70.29) | 2.12 (1.44) | 5.72 (3.60) |
| Cerebral infarction* | 39 | 12.41 (7.32–21.05) | 12.39 (144.35) | 2.71 (1.93) | 12.21 (7.20) | |
| Respiratory, thoracic and mediastinal disorders | Interstitial lung disease | 345 | 6.71 (3.89–11.59) | 6.70 (62.57) | 2.14 (1.33) | 6.66 (3.85) |
| Pleural effusion* | 215 | 25.92 (14.91–45.05) | 25.89 (300.99) | 3.10 (2.28) | 25.08 (14.43) | |
| Pneumonitis | 179 | 9.91 (5.61–17.52) | 9.90 (94.8) | 2.43 (1.59) | 9.79 (5.54) | |
| Lung disorder | 163 | 26.89 (15.12–47.83) | 26.87 (288.82) | 3.04 (2.19) | 26.00 (14.62) | |
| Pulmonary embolism* | 133 | 12.16 (6.87–21.52) | 12.15 (120.91) | 2.58 (1.74) | 11.98 (6.77) | |
| Respiratory failure | 104 | 10.45 (5.76–18.95) | 10.44 (92.68) | 2.41 (1.54) | 10.32 (5.69) | |
| Pneumothorax* | 45 | 3.98 (2.2–7.21) | 3.98 (24.44) | 1.54 (0.67) | 3.97 (2.19) | |
| Pulmonary alveolar haemorrhage | 18 | 4.33 (2.25–8.33) | 4.32 (22.88) | 1.54 (0.58) | 4.31 (2.24) | |
| Pulmonary toxicity | 18 | 35.60 (18.24–69.46) | 35.57 (289.1) | 2.83 (1.85) | 34.05 (17.45) | |
| Lung opacity | 11 | 124.03 (58.79–261.67) | 123.94 (841.01) | 2.90 (1.81) | 106.98 (50.71) | |
| Eosinophilic pneumonia* | 8 | 6.24 (3.11–12.52) | 6.24 (34.93) | 1.80 (0.78) | 6.20 (3.09) | |
| Hydrothorax* | 7 | 5.42 (2.70–10.87) | 5.42 (28.62) | 1.69 (0.66) | 5.39 (2.69) | |
| Pulmonary artery thrombosis* | 5 | 10.37 (5.16–20.84) | 10.36 (66.78) | 2.17 (1.14) | 10.24 (5.10) | |
| Skin and subcutaneous tissue disorders | Nail disorder | 67 | 13.81 (6.54–29.16) | 13.80 (81.64) | 2.21 (1.11) | 13.57 (6.43) |
| Onychoclasis | 59 | 5.16 (2.45–10.86) | 5.16 (23.32) | 1.57 (0.47) | 5.13 (2.44) | |
| Skin disorder | 53 | 5.70 (2.71–11.99) | 5.70 (26.9) | 1.65 (0.55) | 5.66 (2.69) | |
| Dermatitis acneiform* | 43 | 232.51 (93.36–579.09) | 232.38 (1063.33) | 2.54 (1.23) | 178.99 (71.86) | |
| Erythema multiforme* | 38 | 7.25 (3.25–16.21) | 7.25 (32.03) | 1.71 (0.53) | 7.19 (3.22) | |
| Onychalgia | 13 | 8.45 (3.78–18.91) | 8.45 (38.99) | 1.81 (0.62) | 8.37 (3.74) | |
| Ingrowing nail | 12 | 11.46 (4.74–27.73) | 11.46 (47.04) | 1.79 (0.49) | 11.31 (4.67) | |
| Nail discolouration | 9 | 5.62 (2.33–13.54) | 5.61 (18.82) | 1.40 (0.10) | 5.58 (2.31) | |
| Nail bed disorder | 5 | 20.83 (8.57–50.65) | 20.82 (91.89) | 2.00 (0.70) | 20.30 (8.35) | |
| Vascular disorders | Deep vein thrombosis | 72 | 14.19 (5.86–34.38) | 14.19 (60.19) | 1.88 (0.58) | 13.95 (5.76) |
| Venous thrombosis limb | 12 | 28.18 (10.39–76.43) | 28.17 (101.14) | 1.80 (0.33) | 27.21 (10.03) | |
| Thrombophlebitis migrans | 9 | 14.35 (5.34–38.59) | 14.34 (48.76) | 1.64 (0.18) | 14.10 (5.24) |
ROR reporting odds ratio, CI confidence interval, PRR proportional reporting ratio, χ2 chi-squared, IC information component, IC 025 the lower limit of 95% CI of the IC, EBGM empirical Bayesian geometric mean, EBGM 05 the lower limit of 95% CI of EBGM.
*Emerging findings of Osimertinib associated AEs from FAERS database.