| |
Treatment time interval
|
|---|
|
Event, n (%)
|
0–3 months*(n = 9)
|
>3–6 months*(n = 6)
|
>6–12 months*(n = 6)
|
|---|
|
Any TEAE
|
8 (89)
|
5 (83)
|
6 (100)
|
|
Any related TEAE
|
4 (44)
|
1 (17)
|
3 (50)
|
|
Any IAR
|
3 (33)
|
2 (33)
|
3 (50)
|
|
Any serious TEAE
|
7 (78)
|
4 (67)
|
4 (67)
|
|
Any related serious TEAE
|
1 (11)
|
0
|
0
|
|
Dose modification due to a TEAE†
|
3 (33)
|
1 (17)
|
1 (17)
|
|
Discontinuation due to a TEAE
|
0
|
0
|
0
|
|
Death
|
3 (33)
|
0
|
1 (17)
|
|
Death related to treatment
|
0
|
0
|
0
|
-
IAR infusion-associated reaction, TEAE treatment-emergent adverse event
-
*Non-serious adverse event data were unavailable for one patient from week 0 to week 39 (~month 9)
-
†All dose modifications were dose escalations based on inadequate clinical response. These symptoms of inadequate clinical response were also captured as adverse events (see Additional file 1)
