TABLE 3

RI and 95% CI Estimated by SCCS Analysis

RI (95% CI)a
EOICases in Risk Window, nCases in Comparison Window,bnUnadjustedAdjustedc
CRC-reviewed EOIs
 Bell’s palsy8102.7 (1.1–6.8)2.9 (1.1–7.5)
 Multiple sclerosis02. (.). (.)
 Guillain-Barre syndrome00. (.). (.)
 Acute disseminated encephalomyelitis00. (.). (.)
 Cerebellar ataxia00. (.). (.)
 Transverse myelitis01. (.). (.)
 Brachial neuritis00. (.). (.)
 Myasthenia gravis00. (.). (.)
 Systemic lupus erythematosus00. (.). (.)
 Rheumatoid arthritis03. (.). (.)
 Henoch-Schonlein purpura01. (.). (.)
 Juvenile diabetes mellitus381.3 (0.3–4.7)1.2 (0.3–4.7)
 Graves’ disease161.3 (0.2–10.6)1.1 (0.1–10.0)
 Acute glomerulonephritis10. (.). (.)
 Nephrotic syndrome01. (.). (.)
 Meningococcal disease0N/AN/AN/A
Non-CRC reviewed EOIs
 Seizure9722.9 (1.5–5.8)2.9 (1.5–5.9)
 Seizure (chart reviewed)025. (.). (.)
 Iridocyclitis (uveitis)5133.0 (1.1–8.3)3.1 (1.1–8.7)
 Iridocyclitis (uveitis) (chart reviewed)4103.1 (0.96–9.8)3.4 (1.02–11.2)
 Hashimoto disease1385.4 (2.3–13.1)5.5 (2.3–13.3)
 Hashimoto disease (chart reviewed)232.2 (0.4–13.3)5.1 (0.5–55.0)
 Anaphylaxis2104.7 (1.02–21.3)5.5 (1.1–26.2)
 Anaphylaxis (chart reviewed)04. (.). (.)
 ITP117.7 (0.5–123.0). (.)d
 Autoimmune hemolytic anemia01. (.). (.)
 Aseptic meningitis04. (.). (.)
 Asthma2066351.1 (0.9–1.3)1.1 (0.9–1.3)
 Allergic urticaria2271.7 (0.4–7.3)1.8 (0.4–7.4)
 Suicide attempt9641.1 (0.5–2.2)1.1 (0.5–2.2)
Totale260867
  • 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.