Matched SRS-Reported and ADE-S-Reported Events

SRS Event TypeADE-S Event TypeNo. of Matched Events
Severity ≥ 3Causality ≥ 5 and severity ≥ 34
Severity ≤ 2Causality ≥ 5 and severity ≥ 31
Severity ≥ 3All triggers9
Severity ≤ 2All triggers3
All reportsAll triggers12
Matched by event categorya
    Administration dose/rate3
  • Matched ADE-S triggers in the this comparison can have any severity or causality value.

  • a SRS events in these groups have a severity score of ≥3.