TABLE 2

Summary of Case Identification and Review for EOIs

Automated AlgorithmInitial Chart ReviewCRC/ Physician Investigator Review
EOIPotential Cases Identified (a)Excluded Cases Based on Preexisting Condition (b)Cases Identified From Automated Algorithm (c = a–b)Cases Excluded As Preexisting Condition (d)Cases Confirmed (e)Cases Refuted (f)Cases With Onset Determined to Be Before Start of Risk Window (g)Total Cases for Analysis (h = a–b–d–f–g)
CRC-reviewed EOIs
 Bell’s palsy243211182018
 Multiple sclerosis93612302
 Guillain-Barre syndrome00000000
 Acute disseminated encephalomyelitis20200200
 Cerebellar ataxia21110000
 Transverse myelitis20201101
 Brachial neuritis34430202800
 Myasthenia gravis23716201400
 Systemic lupus erythematosus2016404a140
 Rheumatoid arthritis36261027143
 Henoch-Schonlein purpura61512211
 Juvenile diabetes mellitus2362023420122111
 Graves’ disease452817111547
 Acute glomerulonephritis1913612311
 Nephrotic syndrome86211001
 Meningococcal disease20200200
Non-CRC reviewed EOIs
 Seizure1113081N/AN/AN/AN/A81
 Seizure (chart reviewed)bN/AN/AN/AN/A39421425
 Iridocyclitis (uveitis)23518N/AN/AN/AN/A18
 Iridocyclitis (uveitis) (chart reviewed)bN/AN/AN/AN/A153114
 Hashimoto disease735221N/AN/AN/AN/A21
 Hashimoto disease (chart reviewed)bN/AN/AN/AN/A183135
 Anaphylaxis14212N/AN/AN/AN/A12
 Anaphylaxis (chart reviewed)bN/AN/AN/AN/A102c64
 ITP862N/AN/AN/AN/A2
 Autoimmune hemolytic anemia211N/AN/AN/AN/A1
 Aseptic meningitis404N/AN/AN/AN/A4
 Asthma34302589841N/AN/AN/AN/A841
 Allergic urticaria31229N/AN/AN/AN/A29
 Suicide attempt76373N/AN/AN/AN/A73
Totald424030001240335666151127
Number of subjects experiencing a single EOI1099
Number of subjects experiencing multiple different EOIs14
  • N/A, not applicable.

  • a One subject identified from the automated algorithm with acute glomerulonephritis was confirmed as systemic lupus erythematosus.

  • b For non-CRC reviewed EOIs for which elevated RIs were observed in the initial analysis, medical records underwent further review by a physician investigator.

  • c Non-KPSC records were not available with which to verify the medical encounter details for 1 anaphylaxis case in the comparison window. This case was included with refuted cases for the purpose of analyses.

  • d Totals do not include physician investigator chart review data.