Table 5.
Vinorelbine-associated AEs in the cardiac and respiratory systems reported in FAERS.
| SOC classification | PT classification | Report count | ROR (95% Cl) | IC (IC025) |
|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders | Interstitial lung disease | 61 | 11.87 (9.23–15.28) | 3.56 (2.96) |
| Acute pulmonary edema | 7 | 11.11 (5.29–23.33) | 3.47 (1.27) | |
| Pleuritic pain | 3 | 9.71 (3.13–30.13) | 3.28 (0.17) | |
| Rales | 6 | 9.05 (4.06–18.49) | 3.18 (0.98) | |
| Pulmonary toxicity | 6 | 8.30 (3.73–18.49) | 3.05 (0.93) | |
| Pneumonitis | 23 | 8.10 (5.38–12.20) | 3.01 (2.05) | |
| Respiratory acidosis | 3 | 7.02 (2.26–21.77) | 2.81 (0.04) | |
| Lung infiltration | 6 | 5.74 (2.58–12.78) | 2.52 (0.68) | |
| Pleural effusion | 38 | 5.62 (4.08–7.73) | 2.48 (1.86) | |
| Bronchospasm | 9 | 5.61 (2.92–10.79) | 2.49 (1.03) | |
| Hypoxia | 21 | 5.54 (3.61–8.50) | 2.47 (1.58) | |
| Respiratory failure | 40 | 4.95 (3.63–6.76) | 2.30 (1.72) | |
| Atelectasis | 5 | 4.52 (1.88–10.86) | 2.17 (0.33) | |
| Respiratory distress | 13 | 4.26 (2.47–7.33) | 2.09 (1.01) | |
| Haemoptysis | 13 | 4.20 (2.44–7.23) | 2.07 (0.33) | |
| Tachypnoea | 6 | 4.10 (1.84–9.12) | 2.03 (0.41) | |
| Lung disorder | 18 | 3.43 (2.16–5.45) | 1.78 (0.94) | |
| Pulmonary edema | 16 | 3.22 (1.97–5.26) | 1.68 (0.81) | |
| Respiratory disorder | 10 | 3.06 (1.64–5.69) | 1.61 (0.49) | |
| Pulmonary embolism | 31 | 2.89 (2.03–4.11) | 1.53 (0.93) | |
| Dyspnoea exertional | 10 | 2.49 (1.34–4.63) | 1.31 (0.26) | |
| Dyspnoea | 110 | 1.79 (1.48–2.16) | 0.83 (0.54) | |
| Cardiac disorders | Cardiovascular insufficiency | 3 | 16.17 (5.21–50.21) | 4.01 (0.31) |
| Cardiotoxicity | 13 | 14.28 (8.28–24.62) | 3.83 (2.10) | |
| Stress cardiovascular | 7 | 11.66 (5.56–24.49) | 3.54 (1.30) | |
| Ventricular hypertrophy | 3 | 9.82 (3.16–30.47) | 3.29 (0.17) | |
| Acute coronary syndrome | 9 | 9.40 (4.89–18.08) | 3.23 (1.44) | |
| Atrial flutter | 7 | 7.77 (3.70–16.32) | 2.96 (1.05) | |
| Left ventricular failure | 3 | 7.74 (2.49–24.01) | 2.95 (0.08) | |
| Cardiopulmonary failure | 3 | 6.68 (2.15–20.71) | 2.74 (0.02) | |
| Cardiogenic shock | 8 | 5.53 (2.67–10.67) | 2.41 (0.88) | |
| Supraventricular tachycardia | 5 | 4.67 (1.94–11.24) | 2.22 (0.36) | |
| Cardiac failure | 33 | 3.74 (2.66–5.26) | 1.90 (1.29) | |
| Cardiomyopathy | 6 | 3.61 (1.62–8.04) | 1.85 (0.30) | |
| Acute myocardial infarction | 8 | 2.36 (1.18–4.72) | 1.24 (0.07) | |
| Cardio-respiratory arrest | 10 | 2.08 (1.12–3.87) | 1.06 (0.05) | |
| Tachycardia | 19 | 1.95 (1.24–3.06) | 0.96 (0.25) |