Table 4 Signal strength of top 30 reports of Pembrolizumab plus Lenvatinib at the PTs and SOC levels in FAERS database.
PTs | SOC | Case reports | ROR (95% CI) | PRR (95% CI) | χ2 | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|---|
Hepatic encephalopathy | Nervous system disorders | 36 | 375.63 (268.32-525.85) | 356.42 (254.71-498.73) | 12678.74 | 4.58 (5.56) | 252.96 (495.75) |
Blood bilirubin increased | Investigations | 35 | 145.52 (103.55–204.50) | 138.31 (98.46–194.30) | 4760.94 | 4.35 (5.34) | 98.17 (193.89) |
Diarrhoea | Gastrointestinal disorders | 31 | 4.25 (2.97–6.09) | 4.11 (2.87–5.89) | 73.65 | 1.38 (2.42) | 2.86 (5.89) |
Ascites | Gastrointestinal disorders | 21 | 68.67 (44.47-106.04) | 66.65 (43.17-102.89) | 1356.85 | 3.44 (4.69) | 43.11 (102.79) |
Acute kidney injury | Renal and urinary disorders | 15 | 6.88 (4.13–11.48) | 6.76 (4.05–11.27) | 73.82 | 1.58 (3.04) | 4.05 (11.27) |
Alanine aminotransferase increased | Investigations | 14 | 26.33 (15.51–44.71) | 25.83 (15.22–43.84) | 334.24 | 2.53 (4.03) | 15.21 (43.83) |
Malignant neoplasm progression | Malignant and unspecified (incl cysts and polyps) | 14 | 11.33 (6.67–19.23) | 11.12 (6.55–18.88) | 129.15 | 1.98 (3.48) | 6.55 (18.87) |
Hepatic function abnormal | Hepatobiliary disorders | 11 | 30.09 (16.58–54.59) | 29.63 (16.33–53.76) | 304.33 | 2.29 (3.97) | 16.32 (53.74) |
Adverse event | General disorders and administration site conditions | 10 | 9.37 (5.02–17.50) | 9.26 (4.96–17.28) | 73.74 | 1.52 (3.28) | 4.96 (17.28) |
Gastrointestinal haemorrhage | Gastrointestinal disorders | 10 | 9.79 (5.24–18.27) | 9.66 (5.18–18.04) | 77.76 | 1.56 (3.31) | 5.17 (18.04) |
Hypotension | Vascular disorders | 10 | 4.56 (2.44–8.51) | 4.51 (2.41–8.41) | 27.37 | 0.89 (2.65) | 2.41 (8.41) |
Adrenal insufficiency | Endocrine disorders | 9 | 71.82 (37.20-138.68) | 70.91 (36.73-136.92) | 619.66 | 2.23 (4.07) | 36.68 (136.75) |
Hypertension | Vascular disorders | 9 | 3.97 (2.06–7.67) | 3.93 (2.04–7.59) | 19.75 | 0.68 (2.52) | 2.04 (7.59) |
Platelet count decreased | Investigations | 9 | 7.53 (3.90-14.53) | 7.44 (3.86–14.37) | 50.28 | 1.26 (3.10) | 3.86 (14.36) |
Aspartate aminotransferase increased | Investigations | 8 | 18.11 (9.02–36.36) | 17.91 (8.92–35.96) | 127.79 | 1.67 (3.60) | 8.92 (35.95) |
General physical health deterioration | General disorders and administration site conditions | 8 | 6.82 (3.40–13.69) | 6.75 (3.36–13.56) | 39.26 | 1.07 (3.01) | 3.36 (13.55) |
Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 8 | 30.03 (14.95–60.29) | 29.69 (14.79–59.62) | 221.79 | 1.86 (3.79) | 14.78 (59.60) |
Urinary tract infection | Infections and infestations | 8 | 4.11 (2.05–8.25) | 4.07 (2.03–8.18) | 18.60 | 0.63 (2.57) | 2.03 (8.18) |
Dehydration | Metabolism and nutrition disorders | 7 | 5.05 (2.40-10.63) | 5.01 (2.38–10.55) | 22.50 | 0.71 (2.76) | 2.38 (10.55) |
Immune-mediated hepatitis | Hepatobiliary disorders | 7 | 370.77 (175.67-782.56) | 367.08 (173.93-774.75) | 2538.71 | 1.94 (4.00) | 172.77 (769.65) |
Proteinuria | Renal and urinary disorders | 7 | 34.49 (16.38–72.63) | 34.16 (16.22–71.93) | 225.23 | 1.70 (3.76) | 16.21 (71.89) |
Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 7 | 32.65 (15.51–68.77) | 32.34 (15.36–68.10) | 212.53 | 1.69 (3.74) | 15.35 (68.06) |
Colitis | Gastrointestinal disorders | 6 | 14.46 (6.47–32.30) | 14.35 (6.42–32.05) | 74.52 | 1.21 (3.40) | 6.42 (32.04) |
Acute myocardial infarction | Cardiac disorders | 5 | 16.46 (6.83–39.67) | 16.35 (6.78–39.40) | 72.05 | 1.02 (3.38) | 6.78 (39.39) |
Oesophageal varices haemorrhage | Gastrointestinal disorders | 5 | 210.46 (87.18-508.07) | 208.96 (86.56-504.45) | 1030.96 | 1.37 (3.74) | 86.23 (502.56) |
Cholangitis | Hepatobiliary disorders | 4 | 63.56 (23.78-169.93) | 63.21 (23.64-168.97) | 244.63 | 0.94 (3.53) | 23.62 (168.79) |
Hyperkalaemia | Metabolism and nutrition disorders | 4 | 11.11 (4.16–29.69) | 11.05 (4.14–29.54) | 36.59 | 0.58 (3.17) | 4.14 (29.53) |
Hyponatraemia | Metabolism and nutrition disorders | 4 | 6.71 (2.51–17.94) | 6.68 (2.50-17.85) | 19.33 | 0.35 (2.94) | 2.50 (17.85) |
Hypothyroidism | Endocrine disorders | 4 | 12.30 (4.60-32.87) | 12.24 (4.58–32.70) | 41.28 | 0.62 (3.21) | 4.58 (32.69) |
Acute respiratory failure | Thoracic and mediastinal disorders | 3 | 13.82 (4.45–42.97) | 13.77 (4.43–42.80) | 35.52 | 0.27 (3.16) | 4.43 (42.79) |
