Trial Outcomes & Findings for Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy (NCT NCT04770272)
NCT ID: NCT04770272
Last Updated: 2026-01-12
Results Overview
Pathological Complete Response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
442 participants
Primary outcome timeframe
after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.
Results posted on
2026-01-12
Participant Flow
Participants were screened at 34 centers in Germany.The expected number of patients to be recruited was 458. As the study protocol mandated termination of trial recruitment based on the results of the first interim analysis, the final Intention-to-treat (ITT) population was limited to 359 participants.442 participants had been screened, and 2 per arm were excluded from analysis due to protocol violations. First participant enrolled: 2021-03-01; last visit of a participant: 2024-10-02.
Participant milestones
| Measure |
Arm A
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
179
|
|
Overall Study
COMPLETED
|
134
|
131
|
|
Overall Study
NOT COMPLETED
|
46
|
48
|
Reasons for withdrawal
| Measure |
Arm A
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
12
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Adverse Event
|
23
|
21
|
|
Overall Study
Physician Decision
|
7
|
3
|
|
Overall Study
Disease progression
|
4
|
8
|
|
Overall Study
Switched to other therapy.
|
0
|
2
|
Baseline Characteristics
Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy
Baseline characteristics by cohort
| Measure |
Arm A
n=180 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=179 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.57 years
STANDARD_DEVIATION 11.66 • n=9 Participants
|
49.98 years
STANDARD_DEVIATION 12.34 • n=6 Participants
|
49.27 years
STANDARD_DEVIATION 12.01 • n=9 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=9 Participants
|
179 Participants
n=6 Participants
|
358 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
168 Participants
n=9 Participants
|
171 Participants
n=6 Participants
|
339 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
16 Participants
n=9 Participants
|
|
Region of Enrollment
Germany
|
180 participants
n=9 Participants
|
179 participants
n=6 Participants
|
359 participants
n=9 Participants
|
|
ECOG
ECOG = 0
|
169 Participants
n=9 Participants
|
170 Participants
n=6 Participants
|
339 Participants
n=9 Participants
|
|
ECOG
ECOG = 1
|
11 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
HER2 IHC status
0
|
72 Participants
n=9 Participants
|
75 Participants
n=6 Participants
|
147 Participants
n=9 Participants
|
|
HER2 IHC status
1+
|
80 Participants
n=9 Participants
|
82 Participants
n=6 Participants
|
162 Participants
n=9 Participants
|
|
HER2 IHC status
2+
|
28 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
50 Participants
n=9 Participants
|
|
Tumor histology
INFILTRATING DUCTAL
|
171 Participants
n=9 Participants
|
166 Participants
n=6 Participants
|
337 Participants
n=9 Participants
|
|
Tumor histology
INFILTRATING LOBULAR
|
3 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Tumor histology
MIXED
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Tumor histology
MUCINOUS
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Tumor histology
Missing
|
5 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
Tumor grading
GRADE 2
|
21 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
39 Participants
n=9 Participants
|
|
Tumor stage
cT4a
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Tumor grading
GRADE 3
|
159 Participants
n=9 Participants
|
161 Participants
n=6 Participants
|
320 Participants
n=9 Participants
|
|
Tumor stage
cT1c
|
73 Participants
n=9 Participants
|
63 Participants
n=6 Participants
|
136 Participants
n=9 Participants
|
|
Tumor stage
cT2
|
96 Participants
n=9 Participants
|
102 Participants
n=6 Participants
|
198 Participants
n=9 Participants
|
|
Tumor stage
cT3
|
6 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Tumor stage
cT4b
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Tumor stage
cT4c
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Tumor stage
cT4d
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Nodal status
cN0
|
123 Participants
n=9 Participants
|
126 Participants
n=6 Participants
|
249 Participants
n=9 Participants
|
|
Nodal status
cN1
|
41 Participants
n=9 Participants
|
43 Participants
n=6 Participants
|
84 Participants
n=9 Participants
|
|
Nodal status
cN2
|
10 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
|
Nodal status
cN3
|
6 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
HER2 status
LOW (IHC 1+ or 2+/ISH negative)
|
108 Participants
n=9 Participants
|
104 Participants
n=6 Participants
|
212 Participants
n=9 Participants
|
|
HER2 status
NEGATIVE
|
72 Participants
n=9 Participants
|
75 Participants
n=6 Participants
|
147 Participants
n=9 Participants
|
|
HER2 status
POSITIVE
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Hormone receptor status
Borderline Positive (either ER or PR expression is above 1% and <10%)
|
25 Participants
n=9 Participants
|
33 Participants
n=6 Participants
|
58 Participants
n=9 Participants
|
|
Hormone receptor status
Negative
|
155 Participants
n=9 Participants
|
146 Participants
n=6 Participants
|
301 Participants
n=9 Participants
|
|
Weight (kg)
|
72.00 kg
STANDARD_DEVIATION 13.52 • n=9 Participants
|
70.36 kg
STANDARD_DEVIATION 13.65 • n=6 Participants
|
71.18 kg
STANDARD_DEVIATION 13.60 • n=9 Participants
|
|
Percentage of Positive KI-67 Cells
|
69.28 percentage
STANDARD_DEVIATION 17.97 • n=9 Participants
|
69.26 percentage
STANDARD_DEVIATION 17.86 • n=6 Participants
|
69.27 percentage
STANDARD_DEVIATION 17.89 • n=9 Participants
|
|
Cellularity (percentage of tumor volume occupied by invasive tumors cells)
|
39.22 percentage
STANDARD_DEVIATION 20.17 • n=9 Participants
|
38.80 percentage
STANDARD_DEVIATION 20.88 • n=6 Participants
|
39.01 percentage
STANDARD_DEVIATION 20.50 • n=9 Participants
|
|
TILs (percentage)
|
24.68 percentage
STANDARD_DEVIATION 19.64 • n=9 Participants
|
25.10 percentage
STANDARD_DEVIATION 19.38 • n=6 Participants
|
24.89 percentage
STANDARD_DEVIATION 19.49 • n=9 Participants
|
|
PD-L1 expression
|
1.12 percentage
STANDARD_DEVIATION 2.77 • n=9 Participants
|
1.22 percentage
STANDARD_DEVIATION 3.55 • n=6 Participants
|
1.17 percentage
STANDARD_DEVIATION 3.18 • n=9 Participants
|
|
Largest tumor diameter
|
24.79 mm
STANDARD_DEVIATION 2.47 • n=9 Participants
|
25.34 mm
STANDARD_DEVIATION 11.52 • n=6 Participants
|
25.07 mm
STANDARD_DEVIATION 11.99 • n=9 Participants
|
PRIMARY outcome
Timeframe: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.Population: The analysis was performed in the ITT population. The analysis population for the primary endpoint encompassed 339 patients with available pCR status (10 missing in each arm).
Pathological Complete Response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0).
Outcome measures
| Measure |
Arm A
n=170 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=169 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Pathological Complete Response (ypT0/is, ypN0)
pCR = 1 (pCR achieved)
|
112 Participants
|
117 Participants
|
|
Pathological Complete Response (ypT0/is, ypN0)
pCR = 0 (no pCR)
|
58 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: from date of randomization up to 24 monthsPopulation: Safety endpoints are based on a subset of the ITT population that actually received treatment. The safety population included 356 patients, 178 from Arm A and 178 from Arm B. Most frequent AEs (\>10% of patients) by system organ class are shown.
Safety (incidence, relationship, seriousness, and severity of all AEs, SAEs, AESIs coded by medical dictionary for regulatory activities (MedDRA), summarized by Preferred Term and System Organ Class and graded according to common terminology criteria of adverse events (CTCAE V5.0)
Outcome measures
| Measure |
Arm A
n=178 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=178 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Number of Adverse Events by Grade
CTCAE grade - all
|
3281 Adverse Events
|
3313 Adverse Events
|
|
Number of Adverse Events by Grade
CTCAE grade 1
|
1924 Adverse Events
|
1937 Adverse Events
|
|
Number of Adverse Events by Grade
CTCAE grade 2
|
847 Adverse Events
|
849 Adverse Events
|
|
Number of Adverse Events by Grade
CTCAE grade 3
|
376 Adverse Events
|
368 Adverse Events
|
|
Number of Adverse Events by Grade
CTCAE grade 4
|
133 Adverse Events
|
159 Adverse Events
|
|
Number of Adverse Events by Grade
CTCAE grade 5
|
1 Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: after 29-30 weeks in Arm A and after 27-28 weeks in Arm BPopulation: Patients with an ER/PR expression of \<1%. (Data for partients and an ER/PR expression of 1% to 10%, see below.)
Pathological complete response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0) in patients with an ER/PR expression of \<1% and an ER/PR expression of 1% to 10%.
Outcome measures
| Measure |
Arm A
n=147 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=138 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Pathological Complete Response (ypT0/is, ypN0) (ER/PR Expression of <1%).
pCR = 0 (no pCR)
|
53 Participants
|
44 Participants
|
|
Pathological Complete Response (ypT0/is, ypN0) (ER/PR Expression of <1%).
pCR = 1 (pCR achieved)
|
94 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: after 29-30 weeks in Arm A and after 27-28 weeks in Arm BPopulation: Patients with an ER/PR expression of 1% to 10%. (Data for partients an ER/PR expression of \<1%, see above.)
Pathological complete response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0) in patients with an ER/PR expression of \<1% and an ER/PR expression of 1% to 10%.
Outcome measures
| Measure |
Arm A
n=23 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=31 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Pathological Complete Response (ypT0/is, ypN0) (ER/PR Between 1 and 10 %).
pCR = 0 (no pCR)
|
5 Participants
|
8 Participants
|
|
Pathological Complete Response (ypT0/is, ypN0) (ER/PR Between 1 and 10 %).
pCR = 1 (pCR achieved)
|
18 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.Population: Same as f0r Primary Endpoint.
Pathological complete response defined as no tumor cells (invasive and no non-invasive) in the breast but also in the lymph nodes (ypN0, ypT0).
Outcome measures
| Measure |
Arm A
n=170 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=169 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Pathological Complete Response (ypT0, ypN0)
pCR (ypT0, ypN0) = 0 (not achieved)
|
67 Participants
|
58 Participants
|
|
Pathological Complete Response (ypT0, ypN0)
pCR (ypT0, ypN0) = 1 (achieved)
|
103 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.Near pCR defined as residual tumor \<5 mm in the breast irrespective of in situ and lymph nodes status
Outcome measures
| Measure |
Arm A
n=170 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=170 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Near Pathological Complete Response (Near pCR)
pCR (ypT0/is/1a) = 0
|
38 Participants
|
31 Participants
|
|
Near Pathological Complete Response (Near pCR)
pCR (ypT0/is/1a) = 1
|
132 Participants
|
139 Participants
|
SECONDARY outcome
Timeframe: after 29-30 weeks in Arm A and after 27-28 weeks in Arm B.Pathological Complete Response defined as no invasive tumor in the breast, irrespective of lymph node status
Outcome measures
| Measure |
Arm A
n=170 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=170 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Pathological Complete Response (no Invasive Tumor)
pCR (ypT0) = 0
|
63 Participants
|
52 Participants
|
|
Pathological Complete Response (no Invasive Tumor)
pCR (ypT0) = 1
|
107 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: after 14/28 days (+/- 2 days) of treatmentPopulation: Analyzed were available samples of participants (20 missing in arm A; 41 missing in arm B).
Decrease of Ki-67 expression versus baseline after 14/28 days (+/- 2 days) of treatment as continuous predictor. General comment to analysis of secondary biomarker endpoints: biomarker endpoints are analysed as secondary efficacy endpoints. Biomarker endpoints are measured by core biopsy at a central pathology laboratory at two different timepoints. For arm A visit 1 (A1 in tables) corresponds to day 14 in the trial and denotes the measurement after the Atezolizumab monotherapy window. Arm A visit 3 (A3 in tables) corresponds to day 28 and denotes a measurement taken again after two weeks of combined immuno- and chemotherapy. In arm B, only visit 2 (day 14; B2 in tables) is measured after the initial two weeks of combined immuno- and chemotherapy.
Outcome measures
| Measure |
Arm A
n=160 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=138 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Decrease of Ki-67 Expression by ≥ 30% Compared to Baseline as Continuous Predictor After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment
Ki-67 BL Decr. >= 30% A1B2 = 0 (not achieved)
|
142 Participants
|
90 Participants
|
|
Decrease of Ki-67 Expression by ≥ 30% Compared to Baseline as Continuous Predictor After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment
Ki-67 BL Decr. >= 30% A1B2 = 1 (achieved)
|
18 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: after 28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (43 missing in arm A; 41 missing in arm B).
Decrease of Ki-67 expression versus baseline by 30% or more after 28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above. Decrease of Ki-67 defined as ≥ 30% compared to baseline.
Outcome measures
| Measure |
Arm A
n=137 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=138 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Decrease of Ki-67 Expression After 28 Days (+/- 2 Days) of Treatment for Arm A and Arm B.
Ki-67 BL Decr. >= 30% A3B2 = 0 (not achieved)
|
84 Participants
|
90 Participants
|
|
Decrease of Ki-67 Expression After 28 Days (+/- 2 Days) of Treatment for Arm A and Arm B.
Ki-67 BL Decr. >= 30% A3B2 = 1 (achieved)
|
53 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: after 14/28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (20 missing in arm A; 39 missing in arm B).
TILs after 14/28 days (+/- 2 days) of treatment as continuous predictor. See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=160 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=140 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Stromal Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 14 (Arm A)/28 Days (ArmB)
TILs >= 60% A1B2 = 0 (not achieved)
|
134 Participants
|
96 Participants
|
|
Stromal Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 14 (Arm A)/28 Days (ArmB)
TILs >= 60% A1B2 = 1 (achieved)
|
26 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: after 28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (42 missing in arm A; 39 missing in arm B).
TILs ≥ 60% after 28 days (+/- 2 days) of treatment. Stromal Tumor Infiltrating Lymphocytes (TILs) ≥ 60%. See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=138 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=140 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 28 Days
TILs >= 60% A3B2 = 0 (not achieved)
|
102 Participants
|
96 Participants
|
|
Tumor-infiltrating Lymphocytes (TILs) ≥ 60% After 28 Days
TILs >= 60% A3B2 = 1 (achieved)
|
36 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: after 14/28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (20 missing in arm A; 41 missing in arm B).
Complete Cell Cycle Arrest (CCCA): Ki-67 expression ≤ 2.7% after 14/28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=160 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=138 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Complete Cell Cycle Arrest (CCCA) After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment
CCCA A1B2 = 0 (not achieved)
|
160 Participants
|
138 Participants
|
|
Complete Cell Cycle Arrest (CCCA) After 14 (Arm A)/28 Days (armB) (+/- 2 Days) of Treatment
CCCA A1B2 = 1 (achieved)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: after 28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (43 missing in arm A; 41 missing in arm B).
CCCA: Ki-67 expression ≤ 2.7%. Complete Cell Cycle Arrest (CCCA) defined as : Ki-67 ≤ 2.7%. See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=137 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=138 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Complete Cell Cycle Arrest (CCCA) After 28 Days (+/- 2 Days) of Treatment
CCCA A3B2 = 0 (not achieved)
|
136 Participants
|
138 Participants
|
|
Complete Cell Cycle Arrest (CCCA) After 28 Days (+/- 2 Days) of Treatment
CCCA A3B2 = 1 (achieved)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: after 14/28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (20 missing in arm A; 37 missing in arm B).
Low cellularity: \< 500 tumor cells after 14/28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=160 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=142 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Low Cellularity (< 500 Tumor Cells) After 14 (Arm A)/28 Days (Arm B) (+/- 2 Days) of Treatment
Low Cell. A1B2 = 0 (not achieved)
|
152 Participants
|
102 Participants
|
|
Low Cellularity (< 500 Tumor Cells) After 14 (Arm A)/28 Days (Arm B) (+/- 2 Days) of Treatment
Low Cell. A1B2 = 1 (achieved)
|
8 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: after 28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (41 missing in arm A; 37 missing in arm B).
Low cellularity: \< 500 tumor cells after 28 days (+/- 2 days) of treatment. See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=139 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=142 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Low Cellularity (< 500 Tumor Cells) After 28 Days (+/- 2 Days) of Treatment
Low Cell. A3B2 = 0 (not achieved)
|
92 Participants
|
102 Participants
|
|
Low Cellularity (< 500 Tumor Cells) After 28 Days (+/- 2 Days) of Treatment
Low Cell. A3B2 = 1 (achieved)
|
47 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: after 14/28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (19 missing in arm A; 37 missing in arm B).
Combined early response defined by * CCCA (Ki-67 expression \< 2.7%) or * low cellularity or * decrease of Ki-67 expression (versus baseline) by 30% or more or * TILs ≥ 60% See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=161 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=142 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Combined Early Response After 14 (Arm A)/28 (Arm B) Days (+/- 2 Days) of Treatment
Combined Resp. A1B2 = 0 (not achieved)
|
116 Participants
|
53 Participants
|
|
Combined Early Response After 14 (Arm A)/28 (Arm B) Days (+/- 2 Days) of Treatment
Combined Resp. A1B2 = 1 (achieved)
|
45 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: after 28 days (+/- 2 days) of treatmentPopulation: Analyzed were all available samples of participants (41 missing in arm A; 37 missing in arm B).
Combined early response defined by * CCCA (Ki-67 expression \< 2.7%) or * low cellularity or * decrease of Ki-67 expression (versus baseline) by 30% or more or * TILs ≥ 60% See general comments to biomarker endpoints above.
Outcome measures
| Measure |
Arm A
n=139 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=142 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Combined Early Response After 28 Days (+/- 2 Days) of Treatment
Combined Resp. A3B2 = 0 (not achieved)
|
47 Participants
|
53 Participants
|
|
Combined Early Response After 28 Days (+/- 2 Days) of Treatment
Combined Resp. A3B2 = 1 (achieved)
|
92 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: from randomization up to 24 months until date of occurrence of no disease to the first occurrence of disease recurrence or death from any causeDisease free survival (DFS) defined as time from the first date of no disease \[i.e. date of surgery\] to the first occurrence of disease recurrence or death from any cause.
Outcome measures
| Measure |
Arm A
n=180 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=179 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Disease Free Survival (DFS)
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: from randomization up to 24 months until date of death from any cause.Overall survival (OS) defined as length of time from randomization to death from any cause. Given that novel post-neoadjuvant treatment options (on and off-trial) have emerged such as Pembrolizumab, the post-neoadjuvant treatment in the follow-up phase of this study would have been most certainly highly heterogeneous. Thus, completion of follow-up to 3 years was no longer justified. Therefore, follow-up was limited to 2 years and only clinically significant survival signals were observed.
Outcome measures
| Measure |
Arm A
n=180 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=179 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Overall Survival (OS).
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: from randomization up to 24 months until date of death from any cause, failure to achieve remission after induction therapy, relapse in any site, or second malignancyEvent free survival (EFS) defined as length of time after randomization till death from any cause, failure to achieve remission after induction therapy, relapse in any site, or second malignancy
Outcome measures
| Measure |
Arm A
n=180 Participants
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=179 Participants
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Event Free Survival (EFS)
|
20 Participants
|
16 Participants
|
Adverse Events
Arm A
Serious events: 86 serious events
Other events: 178 other events
Deaths: 1 deaths
Arm B
Serious events: 87 serious events
Other events: 178 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=178 participants at risk
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=178 participants at risk
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
7/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
3.9%
7/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.9%
23/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
11.8%
21/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
4/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
2.8%
5/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Anal fissure
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Nausea
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Device related thrombosis
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Fatigue
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
General physical health deterioration
|
6.7%
12/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Non-cardiac chest pain
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Pyrexia
|
12.4%
22/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.7%
12/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Immune system disorders
Drug hypersensitivity
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Immune system disorders
Hypersensitivity
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Immune system disorders
Immune-mediated adverse reaction
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Atypical pneumonia
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Catheter site infection
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
COVID-19
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Device related infection
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Febrile infection
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.7%
3/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Gastrointestinal infection
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Infection
|
1.7%
3/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Influenza
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Pneumonia bacterial
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Sepsis
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Septic shock
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Wound infection
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Alanine aminotransferase
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Blood creatinine increased
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
C-reactive protein increased
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Ejection fraction decreased
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Liver function test increased
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Medical observation
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Neutrophil count decreased
|
1.7%
3/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
2.8%
5/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Headache
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Meningism
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Renal and urinary disorders
Nephritis
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
3/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
1.1%
2/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Surgical and medical procedures
Hospitalisation
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
Other adverse events
| Measure |
Arm A
n=178 participants at risk
2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 840 MG in 14 ML Injection: 840 mg Day 1 for two weeks
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm A: 1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
Arm B
n=178 participants at risk
12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.
Atezolizumab 1200 MG in 20 ML Injection: 1200 mg Day 1 every 3 weeks for 8 cycles
Carboplatin: Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
Paclitaxel: Paclitaxel 80 mg/m² IV weekly x 12 cycles
Epirubicin: 90 mg/m2, day 1 for 4 cycles (12 weeks)
Cyclophosphamide: 600 mg/m2, day 1 for 4 cycles (12 weeks)
Biopsy Arm B: 1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
Surgery: After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
52.2%
93/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
60.7%
108/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Leukopenia
|
28.7%
51/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
27.5%
49/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Neutropenia
|
59.6%
106/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
55.1%
98/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.1%
66/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
37.1%
66/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Constipation
|
24.7%
44/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
29.2%
52/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.8%
46/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
32.6%
58/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.4%
22/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
14.0%
25/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Nausea
|
51.1%
91/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
55.6%
99/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Stomatitis
|
13.5%
24/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
17.4%
31/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
40/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
14.6%
26/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Fatigue
|
55.1%
98/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
59.0%
105/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Mucosal inflammation
|
21.9%
39/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
11.8%
21/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Pyrexia
|
24.7%
44/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
14.6%
26/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Alanine aminotransferase increased
|
26.4%
47/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
20.8%
37/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Aspartate aminotransferase increased
|
19.7%
35/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
11.8%
21/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Neutrophil count decreased
|
21.3%
38/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
26.4%
47/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Platelet count decreased
|
10.7%
19/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
18.5%
33/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
White blood cell count decreased
|
10.1%
18/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
16.3%
29/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.1%
18/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
12.9%
23/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
31/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
18.0%
32/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.7%
28/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
18.0%
32/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Dysgeusia
|
9.0%
16/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
11.2%
20/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Headache
|
21.9%
39/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
23.0%
41/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.3%
29/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
14.0%
25/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Polyneuropathy
|
24.2%
43/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
28.1%
50/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Psychiatric disorders
Insomnia
|
11.2%
20/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
11.8%
21/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.9%
23/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
15.2%
27/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.8%
37/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
17.4%
31/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.1%
91/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
55.6%
99/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.7%
19/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
12.4%
22/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.0%
32/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
15.2%
27/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Vascular disorders
Hot flush
|
18.0%
32/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
11.8%
21/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Cardiac disorders
Tachycardia
|
2.8%
5/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Ear and labyrinth disorders
Vertigo
|
7.3%
13/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
9.6%
17/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
12/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.7%
12/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Eye disorders
Dry eye
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
7/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
17/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Oral pain
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
2.8%
5/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Chills
|
7.9%
14/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Influenza like illness
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
2.8%
5/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Mucosal dryness
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Oedema
|
2.8%
5/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
7.3%
13/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
General disorders
Oedema peripheral
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
9.0%
16/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Immune system disorders
Drug hypersensitivity
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Immune system disorders
Hypersensitivity
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
3.9%
7/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Cystitis
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
2.2%
4/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
3.4%
6/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.9%
14/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
7.3%
13/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
12/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
8.4%
15/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.9%
14/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Dizziness
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Paraesthesia
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Nervous system disorders
Taste disorder
|
7.9%
14/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
13/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
8.4%
15/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
5.6%
10/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
6.7%
12/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
3.9%
7/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.2%
11/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
3.4%
6/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.56%
1/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
4.5%
8/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
|
5.1%
9/178 • AEs were recorded until 30 days after the last dose of study treatment or until initiation of new anticancer therapy, whichever occured first; SAEs were reported until 90 days after the last dose of study treatment or until initiation of new anticancer therapy. Therefore, AEs were usually reported for 29 - 30 weeks for participants in Arm A and 27 - 28 weeks for participants in Arm B. Data for survival analyses (OS, PFS) were assessed from randomization up to 24 months.
In accordance with the protocol and SAP, AEs and SAEs were only collected for the neoadjuvant therapy until surgery. Non-serious adverse events with a frequency between 5 and 10% were not included in the CSR. In order to comply with the reporting requirements of ClinicalTrials.gov, the data for this area was re-evaluated using a different analysis programme (SAS) due to organisational restructuring.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place