RI and 95% CI Estimated by SCCS Analysis
| RI (95% CI)a | ||||
|---|---|---|---|---|
| EOI | Cases in Risk Window, n | Cases in Comparison Window,bn | Unadjusted | Adjustedc |
| CRC-reviewed EOIs | ||||
| Bell’s palsy | 8 | 10 | 2.7 (1.1–6.8) | 2.9 (1.1–7.5) |
| Multiple sclerosis | 0 | 2 | . (.) | . (.) |
| Guillain-Barre syndrome | 0 | 0 | . (.) | . (.) |
| Acute disseminated encephalomyelitis | 0 | 0 | . (.) | . (.) |
| Cerebellar ataxia | 0 | 0 | . (.) | . (.) |
| Transverse myelitis | 0 | 1 | . (.) | . (.) |
| Brachial neuritis | 0 | 0 | . (.) | . (.) |
| Myasthenia gravis | 0 | 0 | . (.) | . (.) |
| Systemic lupus erythematosus | 0 | 0 | . (.) | . (.) |
| Rheumatoid arthritis | 0 | 3 | . (.) | . (.) |
| Henoch-Schonlein purpura | 0 | 1 | . (.) | . (.) |
| Juvenile diabetes mellitus | 3 | 8 | 1.3 (0.3–4.7) | 1.2 (0.3–4.7) |
| Graves’ disease | 1 | 6 | 1.3 (0.2–10.6) | 1.1 (0.1–10.0) |
| Acute glomerulonephritis | 1 | 0 | . (.) | . (.) |
| Nephrotic syndrome | 0 | 1 | . (.) | . (.) |
| Meningococcal disease | 0 | N/A | N/A | N/A |
| Non-CRC reviewed EOIs | ||||
| Seizure | 9 | 72 | 2.9 (1.5–5.8) | 2.9 (1.5–5.9) |
| Seizure (chart reviewed) | 0 | 25 | . (.) | . (.) |
| Iridocyclitis (uveitis) | 5 | 13 | 3.0 (1.1–8.3) | 3.1 (1.1–8.7) |
| Iridocyclitis (uveitis) (chart reviewed) | 4 | 10 | 3.1 (0.96–9.8) | 3.4 (1.02–11.2) |
| Hashimoto disease | 13 | 8 | 5.4 (2.3–13.1) | 5.5 (2.3–13.3) |
| Hashimoto disease (chart reviewed) | 2 | 3 | 2.2 (0.4–13.3) | 5.1 (0.5–55.0) |
| Anaphylaxis | 2 | 10 | 4.7 (1.02–21.3) | 5.5 (1.1–26.2) |
| Anaphylaxis (chart reviewed) | 0 | 4 | . (.) | . (.) |
| ITP | 1 | 1 | 7.7 (0.5–123.0) | . (.)d |
| Autoimmune hemolytic anemia | 0 | 1 | . (.) | . (.) |
| Aseptic meningitis | 0 | 4 | . (.) | . (.) |
| Asthma | 206 | 635 | 1.1 (0.9–1.3) | 1.1 (0.9–1.3) |
| Allergic urticaria | 2 | 27 | 1.7 (0.4–7.3) | 1.8 (0.4–7.4) |
| Suicide attempt | 9 | 64 | 1.1 (0.5–2.2) | 1.1 (0.5–2.2) |
| Totale | 260 | 867 | ||
N/A, not applicable.
↵a The RIs of EOIs with 0 cases in either the risk or comparison window were not calculated.
↵b Comparison window starts from the end of the risk window until the end of the 1-year observation period.
↵c Adjusted for seasonal effect by separating observation period into winter (December 1st to March 31st) and nonwinter periods.
↵d The adjusted RI for ITP could not be calculated. The model could not converge due to there being 1 case in the risk window and 1 case in the comparison window, each in different seasons.
↵e Totals do not include physician investigator chart review data.