TABLE 5.
The signal strength of the top 20 AEs of fingolimod and siponimod according to death reports.
| SOC | PT | N | PRR (χ2) | ROR (95% CI) | IC |
|---|---|---|---|---|---|
| Fingolimod | |||||
| Eye disorders | Macular oedema | 865 | 47.27 (29,986.50) | 47.42 (43.93-51.17) | 5.19 |
| Infections and infestations | Cryptococcal meningoencephalitis | 12 | 32.46 (302.21) | 32.46 (17.42-60.49) | 4.75 |
| Investigations | CSF protein abnormal | 3 | 22.02 (52.68) | 22.02 (6.57-73.84) | 4.28 |
| Infections and infestations | Neurocryptococcosis | 4 | 21.26 (67.88) | 21.26 (7.48-60.49) | 4.23 |
| Investigations | Electrocardiogram PR shortened | 15 | 19.27 (230.97) | 19.27 (11.27-32.96) | 4.11 |
| Investigations | CSF glucose decreased | 6 | 19.27 (92.39) | 19.27 (8.25-45.03) | 4.11 |
| Nervous system disorders | Optic neuritis | 684 | 18.44 (10,080.83) | 18.49 (17.08-20.02) | 4.05 |
| Neoplasms benign, malignant and unspecified | Anaplastic large cell lymphoma T- and null-cell types | 13 | 17.13 (177.70) | 17.13 (9.66-30.38) | 3.96 |
| Nervous system disorders | Paraparesis | 111 | 15.98 (1,412.17) | 15.98 (13.15-19.43) | 3.87 |
| Nervous system disorders | Brain stem syndrome | 31 | 12.45 (301.93) | 12.45 (8.63-17.95) | 3.53 |
| Infections and infestations | JC virus infection | 77 | 12.33 (742.09) | 12.33 (9.78-15.55) | 3.52 |
| Infections and infestations | Meningitis cryptococcal | 73 | 11.93 (678.79) | 11.94 (9.41-15.15) | 3.48 |
| Renal and urinary disorders | Neurogenic bladder | 97 | 11.36 (853.86) | 11.37 (9.25-13.97) | 3.41 |
| Investigations | CSF protein increased | 25 | 10.28 (196.29) | 10.28 (6.86-15.41) | 3.28 |
| Eye disorders | Ophthalmoplegia | 76 | 9.41 (538.45) | 9.41 (7.47-11.87) | 3.16 |
| Nervous system disorders | Neuromyelitis optica spectrum disorder | 51 | 9.29 (356.01) | 9.30 (7.01-12.33) | 3.14 |
| Neoplasms benign, malignant and unspecified | Penile squamous cell carcinoma | 3 | 9.07 (20.34) | 9.07 (2.83-29.06) | 3.11 |
| Neoplasms benign, malignant and unspecified | Squamous cell carcinoma of the cervix | 8 | 9.00 (53.77) | 9.00 (4.41-18.36) | 3.10 |
| Nervous system disorders | Hemiparesis | 567 | 7.70 (3,149.19) | 7.71 (7.09-8.39) | 2.88 |
| Nervous system disorders | Demyelination | 118 | 7.52 (636.09) | 7.52 (6.25-9.05) | 2.85 |
| Siponimod | |||||
| Infections and infestations | JC virus infection | 3 | 5.91 (12.21) | 5.91 (1.90-18.37) | 2.56 |
| Nervous system disorders | Hemiparesis | 33 | 5.68 (126.79) | 5.68 (4.04-8.00) | 2.50 |
| Infections and infestations | Urosepsis | 12 | 3.84 (25.22) | 3.85 (2.18-6.78) | 1.94 |
| Cardiac disorders | Bradycardia | 45 | 2.58 (43.42) | 2.58 (1.93-3.46) | 1.36 |
| Nervous system disorders | Paralysis | 12 | 2.54 (11.15) | 2.54 (1.44-4.47) | 1.34 |
| Infections and infestations | Pyelonephritis | 7 | 2.45 (5.98) | 2.45 (1.17-5.13) | 1.29 |
| Nervous system disorders | Seizure | 109 | 1.99 (54.01) | 2.00 (1.66-2.41) | 0.99 |
| Nervous system disorders | Status epilepticus | 7 | 1.92 (3.08) | 1.92 (0.91-4.03) | 0.94 |
| Infections and infestations | COVID-19 pneumonia | 8 | 1.85 (3.14) | 1.85 (0.93-3.71) | 0.89 |
| Vascular disorders | Hypertensive crisis | 7 | 1.79 (2.45) | 1.79 (0.85-3.76) | 0.84 |
| Psychiatric disorders | Hallucination | 32 | 1.39 (3.44) | 1.39 (0.98-1.96) | 0.47 |
| Renal and urinary disorders | Nephrolithiasis | 17 | 1.10 (0.15) | 1.10 (0.68-1.77) | 0.14 |
| Infections and infestations | Sepsis | 39 | 1.04 (0.06) | 1.04 (0.76-1.42) | 0.05 |
| Cardiac disorders | Acute myocardial infarction | 10 | 1.03 (0.01) | 1.03 (0.55-1.91) | 0.04 |
| Nervous system disorders | Unresponsive to stimuli | 8 | 0.94 (0.03) | 0.94 (0.47-1.88) | −0.09 |
| Nervous system disorders | Cerebrovascular accident | 50 | 0.92 (0.36) | 0.92 (0.70-1.21) | −0.12 |
| Nervous system disorders | Loss of consciousness | 36 | 0.89 (0.48) | 0.89 (0.64-1.24) | −0.17 |
| Nervous system disorders | Cerebral infarction | 7 | 0.86 (0.17) | 0.86 (0.41-1.80) | −0.22 |
| Neoplasms benign, malignant and unspecified | Breast cancer | 27 | 0.76 (1.98) | 0.76 (0.52-1.11) | −0.39 |
| Respiratory, thoracic and mediastinal disorders | Acute respiratory distress syndrome | 4 | 0.74 (0.36) | 0.74 (0.28-1.97) | −0.43 |