Trial Outcomes & Findings for Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy (NCT NCT02903368)
NCT ID: NCT02903368
Last Updated: 2025-06-13
Results Overview
Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Results posted on
2025-06-13
Participant Flow
This is a 2-part study: In part 1, patients will be randomized in 1:1 ratio to receive 6 months of AAPL (Arm 1A) versus 6 months of APL (Arm 1B) followed by RP, stratified by risk factor. In part 2 (post-RP), patients will be randomized in 1:1 ratio to receive an additional 12 months of AAPL (Arm 2A) or observation (Arm 2B) stratified by type of neoadjuvant therapy and pathological T-stage after RP but before cycle 7 day 1 following neoadjuvant therapy.
The part 2 of the study is still in progression and the final data has not been collected
Participant milestones
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
Eligible participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months.
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
Arm 2A: AAPL Adjuvant Therapy (Part 2)
Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
|
Arm 2B: Observation (Part 2)
Eligible participants will be randomized to the observation arm post surgery
|
|---|---|---|---|---|
|
Part 1
STARTED
|
59
|
59
|
0
|
0
|
|
Part 1
COMPLETED
|
55
|
59
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
4
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
42
|
40
|
|
Part 2
COMPLETED
|
0
|
0
|
31
|
38
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
11
|
2
|
Reasons for withdrawal
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
Eligible participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months.
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
Arm 2A: AAPL Adjuvant Therapy (Part 2)
Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
|
Arm 2B: Observation (Part 2)
Eligible participants will be randomized to the observation arm post surgery
|
|---|---|---|---|---|
|
Part 1
Adverse Event
|
3
|
0
|
0
|
0
|
|
Part 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Part 2
Adverse Event
|
0
|
0
|
5
|
0
|
|
Part 2
Subject withdrew after 6 cycles of protocol therapy.
|
0
|
0
|
1
|
0
|
|
Part 2
Subject withdrew after part-2 randomization and remained on observation.
|
0
|
0
|
4
|
0
|
|
Part 2
Subject withdrew after part-2 randomization and received non-protocol therapy.
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
Baseline characteristics by cohort
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
58 years
n=4 Participants
|
61 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
55 participants
n=93 Participants
|
48 participants
n=4 Participants
|
103 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=93 Participants
|
59 participants
n=4 Participants
|
118 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.Population: 114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.
Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=55 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Combined pCR or MRD Rate [Part 1]
|
12 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: At 3 years post RPPopulation: The primary efficacy analysis was the intent-to-treat approach, including all patients who have been randomized into Part 2 of the study.
3-year bPFS rate is defined as the probability of biochemical progression free and survival at 3 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 3-year mark are censored at date last disease evaluation.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=42 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=40 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]
|
81 percentage of subjects
Interval 68.0 to 89.0
|
72 percentage of subjects
Interval 59.0 to 82.0
|
SECONDARY outcome
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.Population: 114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.
Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen at radical prostatectomy (RP).
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=55 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Rate of pCR at RP (Part 1)
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.Population: 114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.
RCB was calculated as "tumor volume (cm\^3) X % cellularity". RCB was analyzed as a continuous score (with median and range) instead of a categorical variable based on the percentile cutoff point, at the time of radical prostatectomy (RP).
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=55 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Median of Residual Cancer Burden (RCB) at RP (Part 1)
|
0.023 (cm^3) * %
Interval 0.0 to 7.8
|
0.075 (cm^3) * %
Interval 0.0 to 6.8
|
SECONDARY outcome
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.Population: 114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.
Presence or cribriform was evaluated by central pathology review of specimens at radical prostatectomy (RP).
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=55 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Frequency of Presenting Cribriform at RP (Part 1)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.Population: 114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.
Intraductal carcinoma was evaluated by central pathology review of specimens at Radical Prostatectomy (RP).
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=55 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Frequency of Presenting Intraductal Carcinoma at RP (Part 1)
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.Population: 114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.
Pathologic specimens were centrally reviewed and counted for positive surgical margins at the time of Radical Prostatectomy (RP).
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=55 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Frequency of Positive Surgical Margins at RP (Part 1)
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.Population: PSA nadir was collected in 115 patients (56 in AAPL Arm and 59 in APL Arm).
Prostate specific antigen (PSA) was measured on day 1 of each cycle during the neoadjuvant therapy. PSA nadir was defined as the lowest PSA value prior to Radical Prostatectomy (RP). Number and percent of participants with nadir PSA \< 0.2 ng/mL were reported.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=56 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)
|
55 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Assessed post-RP, at 6 months from the initiation of neoadjuvant therapy.Population: Assessed in 114 patients (55 in AAPL Arm and 59 in APL Arm) who received RP, excluding the four who withdrew prior to RP.
Intra-operative complications were collected via questionnaire following Radical Prostatectomy.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=55 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Frequency of Presenting Intra-operative Complications Following RP (Part 1)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 2 years post RP2-year bPFS rate is defined as the probability of biochemical progression free and survival at 2 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 2-year mark are censored at date of last disease evaluation.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=42 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=40 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]
|
90 percentage of subjects
Interval 79.0 to 96.0
|
80 percentage of subjects
Interval 67.0 to 88.0
|
SECONDARY outcome
Timeframe: At 4 years post RP4-year bPFS rate is defined as the probability of biochemical progression free and survival at 4 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 4-year mark are censored at date of last disease evaluation.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=42 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=40 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]
|
67 percentage of subjects
Interval 53.0 to 78.0
|
61 percentage of subjects
Interval 47.0 to 73.0
|
SECONDARY outcome
Timeframe: At 2-years post RPDefined as the probability of freedom from further anti-cancer therapy at 2-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 2-year mark are censored at date of last follow-up.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=42 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=40 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)
|
90 percentage of subjects
Interval 80.0 to 96.0
|
80 percentage of subjects
Interval 67.0 to 88.0
|
SECONDARY outcome
Timeframe: At 3 years post RPDefined as the probability of freedom from further anti-cancer therapy at 3-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 3-year mark are censored at date of last follow-up.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=42 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=40 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)
|
83 percentage of subjects
Interval 71.0 to 91.0
|
72 percentage of subjects
Interval 59.0 to 82.0
|
SECONDARY outcome
Timeframe: At 4-years post RPDefined as the probability of freedom from further anti-cancer therapy at 4-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 4-year mark are censored at date of last follow-up.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=42 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=40 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)
|
78 percentage of subjects
Interval 65.0 to 87.0
|
67 percentage of subjects
Interval 53.0 to 78.0
|
SECONDARY outcome
Timeframe: At 6-months post-RPPopulation: 32 subjects receiving Arm 2A and 34 receiving Arm 2B completed EPIC-26 QOL questionnaires at 6 months post RP.
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=32 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=34 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
Urinary Irritative
|
90 Score on 0-100
Standard Deviation 11
|
92 Score on 0-100
Standard Deviation 8
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
Urinary Incontinence
|
63 Score on 0-100
Standard Deviation 24
|
72 Score on 0-100
Standard Deviation 23
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
Bowel
|
95 Score on 0-100
Standard Deviation 11
|
96 Score on 0-100
Standard Deviation 7
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
Sexual
|
17 Score on 0-100
Standard Deviation 19
|
14 Score on 0-100
Standard Deviation 14
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
Hormonal
|
68 Score on 0-100
Standard Deviation 20
|
83 Score on 0-100
Standard Deviation 16
|
SECONDARY outcome
Timeframe: At 12-months post-RPPopulation: 32 subjects receiving Arm 2A and 39 receiving Arm 2B completed EPIC-26 QOL questionnaires at 12 months post RP.
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=32 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=39 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
Urinary Irritative
|
91 score on 0-100 scale
Standard Deviation 11
|
91 score on 0-100 scale
Standard Deviation 10
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
Urinary Incontinence
|
75 score on 0-100 scale
Standard Deviation 24
|
74 score on 0-100 scale
Standard Deviation 25
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
Bowel
|
95 score on 0-100 scale
Standard Deviation 12
|
94 score on 0-100 scale
Standard Deviation 12
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
Sexual
|
16 score on 0-100 scale
Standard Deviation 18
|
26 score on 0-100 scale
Standard Deviation 26
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
Hormonal
|
68 score on 0-100 scale
Standard Deviation 22
|
86 score on 0-100 scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: At 24-months post-RPPopulation: 14 subjects receiving Arm 2A and 12 receiving Arm 2B completed EPIC-26 QOL questionnaires at 24 months post RP. The QOL questionnaire completion rate was low at the 24-month visit. Due to the Covid19 pandemic, many follow-up visits were conducted virtually. These questionnaires were done when possible and the patients were back in the clinic.
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.
Outcome measures
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=14 Participants
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=12 Participants
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
|---|---|---|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
Urinary Irritative
|
92 score on 0-100 scale
Standard Deviation 12
|
93 score on 0-100 scale
Standard Deviation 9
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
Urinary Incontinence
|
75 score on 0-100 scale
Standard Deviation 22
|
76 score on 0-100 scale
Standard Deviation 30
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
Bowel
|
95 score on 0-100 scale
Standard Deviation 12
|
97 score on 0-100 scale
Standard Deviation 4
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
Sexual
|
31 score on 0-100 scale
Standard Deviation 31
|
26 score on 0-100 scale
Standard Deviation 30
|
|
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
Hormonal
|
88 score on 0-100 scale
Standard Deviation 20
|
90 score on 0-100 scale
Standard Deviation 8
|
Adverse Events
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
Serious events: 8 serious events
Other events: 59 other events
Deaths: 0 deaths
Arm 1B: APL Neoadjuvant Therapy (Part 1)
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Arm 2A: AAPL Adjuvant Therapy (Part 2)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Arm 2B: Observation (Part 2)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=59 participants at risk
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 participants at risk
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
Arm 2A: AAPL Adjuvant Therapy (Part 2)
n=37 participants at risk
Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
Of the 42 patients randomized to Arm 2A, only 37 patients received the AAPL treatment; 5 patients declined protocol treatment after part-2 randomization. Therefore, toxicities for Arm 2A were reported among the 37 patients who actually received AAPL treatment.
|
Arm 2B: Observation (Part 2)
n=38 participants at risk
Eligible participants will be randomized to the observation arm post surgery.
Of the 40 patients randomized to Arm 2B (observation), 38 remained on observation and 2 received non-protocol therapy. Therefore, the AE analysis for Arm 2B included the 38 patients on observation, excluding 2 patient receiving non-protocol therapy.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
8.5%
5/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lipase increased
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Skin infection
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Sepsis
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)
n=59 participants at risk
Eligible Participants will be randomized to receive:
AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months
|
Arm 1B: APL Neoadjuvant Therapy (Part 1)
n=59 participants at risk
Eligible Participants will be randomized to receive:
APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
|
Arm 2A: AAPL Adjuvant Therapy (Part 2)
n=37 participants at risk
Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
Of the 42 patients randomized to Arm 2A, only 37 patients received the AAPL treatment; 5 patients declined protocol treatment after part-2 randomization. Therefore, toxicities for Arm 2A were reported among the 37 patients who actually received AAPL treatment.
|
Arm 2B: Observation (Part 2)
n=38 participants at risk
Eligible participants will be randomized to the observation arm post surgery.
Of the 40 patients randomized to Arm 2B (observation), 38 remained on observation and 2 received non-protocol therapy. Therefore, the AE analysis for Arm 2B included the 38 patients on observation, excluding 2 patient receiving non-protocol therapy.
|
|---|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Agitation
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alanine aminotransferase increased
|
23.7%
14/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
37.3%
22/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Anemia
|
6.8%
4/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
13.6%
8/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
22.0%
13/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
33.9%
20/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.5%
5/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Cataract
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Chills
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Cholesterol high
|
6.8%
4/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Cognitive disturbance
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
8.5%
5/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.5%
5/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Creatinine increased
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Depression
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
6.8%
4/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
10.8%
4/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dizziness
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
6.8%
4/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Dry eye
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dysgeusia
|
8.5%
5/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dysphasia
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limbs
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
16.9%
10/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
22.0%
13/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Facial pain
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
50.8%
30/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
50.8%
30/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
27.0%
10/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Flashing lights
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Flu like symptoms
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Flushing
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
6.8%
4/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.5%
5/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Glaucoma
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Gynecomastia
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Headache
|
13.6%
8/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
18.6%
11/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Hematuria
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hot flashes
|
86.4%
51/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
84.7%
50/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
27.1%
16/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
18.6%
11/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
27.0%
10/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Injection site reaction
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
15.3%
9/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
10.2%
6/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Investigations - Other, specify
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Irritability
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Libido decreased
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
11.9%
7/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Localized edema
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Memory impairment
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Mucosal infection
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
8.5%
5/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
13.6%
8/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
10.2%
6/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain
|
6.8%
4/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
10.8%
4/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Photophobia
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Pleural infection
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.3%
12/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
7.9%
3/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Skin infection
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.4%
2/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Syncope
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Testicular pain
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Upper respiratory infection
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Urethral anastomotic leak
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary frequency
|
11.9%
7/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
10.2%
6/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary incontinence
|
37.3%
22/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
35.6%
21/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
10.8%
4/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
21.1%
8/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary retention
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight gain
|
1.7%
1/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.1%
3/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
5.3%
2/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight loss
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
3.4%
2/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.7%
1/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/59 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
8.1%
3/37 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
2.6%
1/38 • Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place