Table 3.
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