Table 3.
Signal strength of AEs of durvalumab at the PT level in FAERS database
| PT | Case (n) |
ROR (95% CI) |
PRR (χ²) |
IC (IC025) |
EBGM (EBGM05) |
|---|---|---|---|---|---|
| Death* | 1719 |
3.19 (3.01–3.37) |
3.00 (1760.73) |
1.31 (1.23) |
2.48 (2.35) |
| Malignant neoplasm progression | 882 |
1.17 (1.09–1.26) |
1.16 (18.53) |
0.19 (0.09) |
1.14 (1.06) |
| Radiation pneumonitis* | 704 |
56.06 (45.94–68.42) |
54.10 (5096.23) |
3.06 (2.89) |
8.34 (6.84) |
| Pneumonitis* | 540 |
3.41 (3.08–3.77) |
3.34 (646.53) |
1.43 (1.28) |
2.69 (2.43) |
| Pneumonia | 288 |
1.68 (1.48–1.91) |
1.67 (66.28) |
0.65 (0.46) |
1.57 (1.38) |
| Dyspnoea | 263 |
1.53 (1.35–1.75) |
1.53 (41.12) |
0.53 (0.34) |
1.45 (1.27) |
| Pyrexia | 236 |
0.85 (0.75–0.98) |
0.85 (5.37) |
-0.20 (-0.40) |
0.87 (0.76) |
| Interstitial lung disease | 233 |
1.28 (1.11–1.47) |
1.28 (12.28) |
0.31 (0.11) |
1.24 (1.08) |
| Diarrhoea | 232 |
0.82 (0.71–0.93) |
0.82 (8.72) |
-0.26 (-0.46) |
0.83 (0.73) |
| Neutrophil count decreased | 219 |
2.37 (2.04–2.75) |
2.35 (134.46) |
1.04 (0.82) |
2.06 (1.78) |
| Metastases to central nervous system* | 209 |
9.07 (7.47–11.01) |
8.98 (730.39) |
2.30 (2.02) |
4.92 (4.06) |
| Febrile neutropenia | 190 |
1.71 (1.46-2.00) |
1.70 (46.16) |
0.67 (0.43) |
1.59 (1.36) |
| Fatigue | 186 |
0.65 (0.56–0.75) |
0.65 (32.33) |
-0.56 (-0.78) |
0.68 (0.58) |
| Rash | 170 |
0.77 (0.66–0.90) |
0.77 (10.98) |
-0.34 (-0.57) |
0.79 (0.67) |
| Platelet count decreased | 163 |
1.35 (1.14–1.59) |
1.34 (12.43) |
0.38 (0.13) |
1.30 (1.10) |
| Myelosuppression | 152 |
1.83 (1.53–2.18) |
1.82 (46.89) |
0.75 (0.49) |
1.68 (1.41) |
| Hepatic function abnormal | 131 |
1.24 (1.03–1.49) |
1.24 (5.43) |
0.28 (0.01) |
1.21 (1.01) |
| Pleural effusion | 131 |
1.78 (1.47–2.15) |
1.77 (36.92) |
0.72 (0.44) |
1.64 (1.36) |
| Cough | 125 |
1.70 (1.40–2.05) |
1.69 (29.64) |
0.66 (0.37) |
1.58 (1.30) |
| Hypothyroidism | 121 |
0.76 (0.63–0.92) |
0.76 (8.21) |
-0.35 (-0.62) |
0.78 (0.65) |
| Off label use | 121 |
0.45 (0.38–0.54) |
0.46 (75.84) |
-1.05 (-1.31) |
0.48 (0.40) |
| Asthenia | 119 |
0.78 (0.64–0.94) |
0.78 (6.92) |
-0.33 (-0.60) |
0.80 (0.66) |
| Nausea | 116 |
0.63 (0.52–0.76) |
0.63 (23.60) |
-0.61 (-0.88) |
0.66 (0.54) |
| Lung disorder* | 113 |
2.54 (2.06–3.13) |
2.53 (81.10) |
1.13 (0.81) |
2.18 (1.77) |
| Drug-induced liver injury* | 112 |
3.83 (3.07–4.78) |
3.81 (161.86) |
1.56 (1.22) |
2.96 (2.37) |
| Decreased appetite | 111 |
0.60 (0.49–0.72) |
0.60 (28.13) |
-0.68 (-0.96) |
0.62 (0.52) |
| Disease progression | 110 |
0.80 (0.66–0.98) |
0.80 (4.84) |
-0.29 (-0.57) |
0.82 (0.67) |
| Vomiting | 109 |
0.91 (0.75–1.11) |
0.91 (0.85) |
-0.12 (-0.41) |
0.92 (0.75) |
| Colitis | 109 |
0.92 (0.75–1.12) |
0.92 (0.69) |
-0.11 (-0.40) |
0.93 (0.76) |
| Anaemia | 108 |
0.73 (0.60–0.89) |
0.73 (9.94) |
-0.41 (-0.70) |
0.75 (0.62) |
*, positive signal. The positive signal generation conditions were as follows: i) number of cases ≥ 3; ii) ROR 95% CI lower limit > 1; iii) PRR ≥ 2, χ²≥4; iv) IC025 > 0; v) EBGM05 > 2. Only the top 30 most frequent PTs are shown. PT, preferred term