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. 2022 Apr 27;71(12):2913–2928. doi: 10.1007/s00262-022-03202-8

Table 3.

(Serious) adverse events

Pat. No AE/ SAE Event Max intensity (CTCAE grade) Outcome Relationship to investigational product
1 AE iron overload 1 not recovered/ resolved No
1 AE headache 1 recovered/ resolved No
1 AE dizziness 1 recovered/ resolved No
1 AE infection of the upper respiratory tract 1 recovered/ resolved No
1 AE joint pain 1 recovered/ resolved No
1 AE heart burn 1 recovered/ resolved No
1 AE bronchial infection 2 recovered/ resolved No
1 SAE infection with fever 3 not recovered/ resolved No
2 SAE diverticulitis 3 recovered/ resolved No
2 AE anemia 3 recovered/ resolved No
3 AE headache 2 recovered/ resolved No
3 AE nausea 1 recovered/ resolved No
3 AE injection site pain 2 recovered/ resolved Yes
3 AE diarrhea intermittent 1 recovered/ resolved No
3 AE fever 1 recovered/ resolved No
4 SAE dyspnea 3 recovered/ resolved No
4 SAE leukocytosis 4 recovered/ resolved No
4 SAE pneumonia 3 recovered/ resolved No
5 AE verrucosis 1 not recovered/ resolved No
5 AE pruritus both legs 1 recovered/ resolved No
5 AE arrhythmia 1 recovered/ resolved No
5 AE depression mental 1 not recovered/ resolved No
5 AE injection site inflammation 1 recovered/ resolved Yes
5 AE syncope 3 recovered/ resolved No
5 SAE bronchitis 3 recovered/ resolved No
5 SAE bronchitis 3 recovered/ resolved No
5 SAE pneumonia 2 recovered/ resolved No
5 SAE fever 2 recovered/ resolved No
5 AE recurrence CLL 1 not recovered/ resolved No
5 SAE hypercalcemia 4 recovered/ resolved No
5 AE syncope 3 recovered/ resolved No
5 AE chill 1 recovered/ resolved No

Table demonstrating (serious) adverse event during the clinical course of therapy. AE Adverse event. SAE Serious adverse event