Trial Outcomes & Findings for Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer (NCT NCT01901146)
NCT ID: NCT01901146
Last Updated: 2019-08-07
Results Overview
Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS). Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
725 participants
Primary outcome timeframe
3 to 7 weeks after the last dose of study drug in the neoadjuvant phase
Results posted on
2019-08-07
Participant Flow
This study was conducted at 123 sites in 20 countries from April 2013 to January 2017. The study consisted of a neoadjuvant treatment phase for 4 cycles, surgery, and adjuvant treatment for up to one year from the first day of study drug administration in the neoadjuvant phase.
Enrolled patients received run-in chemotherapy consisting of epirubicin and cyclophosphamide every 3 weeks for 4 cycles. After the run-in, participants with adequate cardiac function were randomized. Randomization was stratified by tumor stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.
Participant milestones
| Measure |
ABP 980
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Trastuzumab
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
ABP 980/ABP 980
After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Trastuzumab/Trastuzumab
After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Trastuzumab/ABP 980
After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
|---|---|---|---|---|---|
|
Neoadjuvant Phase
STARTED
|
364
|
361
|
0
|
0
|
0
|
|
Neoadjuvant Phase
COMPLETED
|
358
|
347
|
0
|
0
|
0
|
|
Neoadjuvant Phase
NOT COMPLETED
|
6
|
14
|
0
|
0
|
0
|
|
Adjuvant Phase
STARTED
|
0
|
0
|
349
|
171
|
171
|
|
Adjuvant Phase
COMPLETED
|
0
|
0
|
323
|
164
|
157
|
|
Adjuvant Phase
NOT COMPLETED
|
0
|
0
|
26
|
7
|
14
|
Reasons for withdrawal
| Measure |
ABP 980
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Trastuzumab
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
ABP 980/ABP 980
After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Trastuzumab/Trastuzumab
After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Trastuzumab/ABP 980
After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
|---|---|---|---|---|---|
|
Neoadjuvant Phase
Death
|
1
|
2
|
0
|
0
|
0
|
|
Neoadjuvant Phase
Disease Progression or Recurrence
|
2
|
3
|
0
|
0
|
0
|
|
Neoadjuvant Phase
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Neoadjuvant Phase
Physician Decision
|
1
|
2
|
0
|
0
|
0
|
|
Neoadjuvant Phase
Withdrawal by Subject
|
2
|
5
|
0
|
0
|
0
|
|
Neoadjuvant Phase
Requirement for Alternative Therapy
|
0
|
1
|
0
|
0
|
0
|
|
Adjuvant Phase
Other
|
0
|
0
|
1
|
0
|
0
|
|
Adjuvant Phase
Death
|
0
|
0
|
0
|
0
|
3
|
|
Adjuvant Phase
Disease Progression or Recurrence
|
0
|
0
|
12
|
4
|
3
|
|
Adjuvant Phase
Physician Decision
|
0
|
0
|
9
|
2
|
4
|
|
Adjuvant Phase
Withdrawal by Subject
|
0
|
0
|
4
|
1
|
4
|
Baseline Characteristics
Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer
Baseline characteristics by cohort
| Measure |
ABP 980
n=364 Participants
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Trastuzumab
n=361 Participants
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Total
n=725 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 11.29 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
|
Age, Customized
< 50 years
|
140 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Age, Customized
≥ 50 years
|
224 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
451 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
364 Participants
n=5 Participants
|
361 Participants
n=7 Participants
|
725 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
331 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
664 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
332 Participants
n=5 Participants
|
324 Participants
n=7 Participants
|
656 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not allowed to collect
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tumor Stage
< T4
|
282 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
563 Participants
n=5 Participants
|
|
Tumor Stage
T4
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Axilla Lymph Node Involvement
Yes
|
277 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
543 Participants
n=5 Participants
|
|
Axilla Lymph Node Involvement
No
|
87 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Hormone Receptor Status
Estrogen and/or progesterone receptor positive
|
265 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
533 Participants
n=5 Participants
|
|
Hormone Receptor Status
Estrogen and progesterone receptor negative
|
99 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Paclitaxel Dosing Schedule
Every 3 weeks
|
256 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Paclitaxel Dosing Schedule
Every week
|
108 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Geographic Region
Eastern Europe
|
271 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
544 Participants
n=5 Participants
|
|
Geographic Region
Western Europe
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Geographic Region
Other
|
50 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phasePopulation: The pCR evaluable population, which included all randomized participants who received any amount of study drug, underwent the surgery, and had a non-missing evaluable pCR assessment from the local laboratory evaluation.
Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS). Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
Outcome measures
| Measure |
ABP 980
n=358 Participants
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Trastuzumab
n=338 Participants
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
|---|---|---|
|
Percentage of Participants With a Pathologic Complete Response
|
48.0 percentage of participants
|
40.5 percentage of participants
|
SECONDARY outcome
Timeframe: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phasePopulation: pCR evaluable population
Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue, regardless of residual ductal carcinoma in situ (DCIS). Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
Outcome measures
| Measure |
ABP 980
n=358 Participants
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Trastuzumab
n=338 Participants
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
|---|---|---|
|
Percentage of Participants With a Pathologic Complete Response in Breast Tissue Only
|
51.1 percentage of participants
|
45.0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phasePopulation: pCR evaluable population
Pathological complete response was defined as the absence of invasive tumor cells in the breast tissue and axillary lymph node(s) and absence of residual DCIS. Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
Outcome measures
| Measure |
ABP 980
n=358 Participants
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Trastuzumab
n=338 Participants
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
|---|---|---|
|
Percentage of Participants With a Pathologic Complete Response in Breast Tissue and Axillary Lymph Nodes and Absence of DCIS
|
37.7 percentage of participants
|
29.6 percentage of participants
|
Adverse Events
Neoadjuvant Phase: ABP 980
Serious events: 18 serious events
Other events: 227 other events
Deaths: 0 deaths
Neoadjuvant Phase: Trastuzumab
Serious events: 5 serious events
Other events: 220 other events
Deaths: 0 deaths
Adjuvant Phase: ABP 980/ABP 980
Serious events: 18 serious events
Other events: 124 other events
Deaths: 0 deaths
Adjuvant Phase: Trastuzumab/Trastuzumab
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Adjuvant Phase: Trastuzumab/ABP 980
Serious events: 6 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Phase: ABP 980
n=364 participants at risk
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Neoadjuvant Phase: Trastuzumab
n=361 participants at risk
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Adjuvant Phase: ABP 980/ABP 980
n=349 participants at risk
After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Adjuvant Phase: Trastuzumab/Trastuzumab
n=171 participants at risk
After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Adjuvant Phase: Trastuzumab/ABP 980
n=171 participants at risk
After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.82%
3/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
1/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Gait disturbance
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Hypersensitivity
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Incision site infection
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.55%
2/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
1/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Drug dispensing error
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
1/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
1/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
1/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
White blood cell count decreased
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
1/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
1/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vena cava thrombosis
|
0.27%
1/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Neoadjuvant Phase: ABP 980
n=364 participants at risk
Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Neoadjuvant Phase: Trastuzumab
n=361 participants at risk
Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.
|
Adjuvant Phase: ABP 980/ABP 980
n=349 participants at risk
After surgery, participants initially randomized to ABP 980 continued to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Adjuvant Phase: Trastuzumab/Trastuzumab
n=171 participants at risk
After surgery, participants originally randomized to trastuzumab were re-randomized and continued to receive trastuzumab at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
Adjuvant Phase: Trastuzumab/ABP 980
n=171 participants at risk
After surgery, participants originally randomized to trastuzumab were re-randomized and switched to receive ABP 980 at a dose of 6 mg/kg IV infusion Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.0%
40/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.5%
38/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
17/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.1%
7/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
10/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.8%
21/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
16/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
15/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
5/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
8/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.6%
53/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
45/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.2%
25/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
10/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
6/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
23/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
19/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
9/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.3%
4/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
21/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
18/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
11/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
3/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
14.8%
54/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.3%
59/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
17/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.1%
7/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
10/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.6%
37/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.9%
17/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.4%
16/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.3%
63/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.2%
55/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.7%
20/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
9/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
9/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
12/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
29/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.29%
1/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
3/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
34/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.6%
31/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.57%
2/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
3/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
14.0%
51/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.9%
43/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.3%
8/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
3/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
4.7%
17/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
21/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
6/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.58%
1/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.9%
25/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.1%
22/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.86%
3/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.2%
19/364 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
23/361 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.86%
3/349 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
2/171 • Neoadjuvant phase: From the first dose of study drug until 30 days after last dose in the neoadjuvant phase or until the start of the adjuvant phase, up to 16 weeks. Adjuvant phase: From the first dose of study drug after surgery until 30 days after last dose; approximately 40 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER