Abstract P112 – Table 1. MedDRA Preferred Terms selected for analysis of influenza‐like adverse events and influenza‐like adverse events of interest. MedDRA Preferred Terms used to define influenza‐like adverse events (flu‐like AEs) and influenza‐like adverse events of interest (flu‐like AEI) are shown. The list of flu‐like AEI was selected on the basis of potential clinical significance given the preferred term and adverse event grade. | |
---|---|
Influenza‐like adverse events (all grades) | Influenza‐like adverse events of interest |
Cytokine release syndrome | Cytokine release syndrome ‐ any grade |
Hemophagocytic lymphohistiocytosis | |
Cytokine storm | |
Capillary leak syndrome | |
Pyrexia | Pyrexia ‐ any grade |
Chills | Chills ‐ any grade |
Headache | Headache grade ≥2 |
Fatigue | Fatigue grade ≥2 |
Cancer fatigue | |
Arthralgia | |
Nausea | |
Vomiting | |
Systemic inflammatory response syndrome | |
Hypotension | |
Hypoxia | |
Influenza‐like illness | Influenza‐like illness ‐ any grade |
Myalgia | Myalgia grade ≥2 |
Influenza | Influenza ‐ any grade |
Malaise | Malaise grade ≥2 |