Table 4.
Summary of TEAEs and TESAEs in the four groups
| |
Arm A |
Arm B |
Arm C |
Arm D |
|
|---|---|---|---|---|---|
|
(N=59) |
(N=62) |
(N=58) |
(N=59) |
||
| N(%) | N(%) | N(%) | N(%) | ||
| TEAEs: |
|
|
|
|
|
| Subject with at least one TEAE |
57 (96.6) |
58 (93.5) |
53 (91.4) |
56 (94.9) |
|
| Subject discontinued the study due to TEAE |
4 (6.8) |
4 (6.5) |
6 (10.3) |
8 (13.6) |
|
| Subjects with at least one chemotherapy-related TEAE |
56 (94.9) |
57 (91.9) |
50 (86.2) |
55 (93.2) |
|
| Subjects without TEAE |
2 (3.4) |
4 (6.5) |
5 (8.6) |
3 (5.1) |
|
| TESAEs: |
|
|
|
|
|
| Subject with at least one TESAE |
9 (15.3) |
10 (16.0) |
7 (12.1) |
11 (18.6) |
|
| Subjects with at least one chemotherapy-related TESAE | 5 (8.5) | 4 (6.5) | 3 (5.2) | 5 (8.5) |
Arm A: docetaxel and gemcitabine with 3-weekly schedule; Arm B: paclitaxel and gemcitabine with 3-weekly schedule; Arm C: docetaxel and gemcitabine with weekly schedule; Arm D: paclitaxel and gemcitabine with weekly schedule.
TEAE: Treatment-emergent Adverse Events, TESAE: Treatment-emergent Serious Adverse Events.