Trial Outcomes & Findings for A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer (NCT NCT02623972)

NCT ID: NCT02623972

Last Updated: 2025-11-25

Results Overview

Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks.

Results posted on

2025-11-25

Participant Flow

February 2016 to December 2020

Participant milestones

Participant milestones
Measure
Arm A: Eribulin followed by AC
* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Arm B: AC followed by Eribulin
* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Overall Study
STARTED
16
6
Overall Study
COMPLETED
16
6
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A: Eribulin Followed by AC
n=16 Participants
* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Arm B: AC Followed by Eribulin
n=6 Participants
* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Total
n=22 Participants
Total of all reporting groups
Breast Cancer Stage
IIIC
2 Participants
n=45 Participants
1 Participants
n=12929 Participants
3 Participants
n=6349 Participants
Age, Continuous
57 years
n=45 Participants
59 years
n=12929 Participants
58 years
n=6349 Participants
Sex: Female, Male
Female
16 Participants
n=45 Participants
6 Participants
n=12929 Participants
22 Participants
n=6349 Participants
Sex: Female, Male
Male
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
n=45 Participants
6 Participants
n=12929 Participants
22 Participants
n=6349 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Race (NIH/OMB)
Asian
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Race (NIH/OMB)
White
16 Participants
n=45 Participants
5 Participants
n=12929 Participants
21 Participants
n=6349 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=45 Participants
1 Participants
n=12929 Participants
1 Participants
n=6349 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=45 Participants
0 Participants
n=12929 Participants
0 Participants
n=6349 Participants
Region of Enrollment
United States
16 participants
n=45 Participants
6 participants
n=12929 Participants
22 participants
n=6349 Participants
Estrogen Receptor Status
<1%
3 Participants
n=45 Participants
0 Participants
n=12929 Participants
3 Participants
n=6349 Participants
Estrogen Receptor Status
1-10%
0 Participants
n=45 Participants
1 Participants
n=12929 Participants
1 Participants
n=6349 Participants
Estrogen Receptor Status
>10%
13 Participants
n=45 Participants
5 Participants
n=12929 Participants
18 Participants
n=6349 Participants
Breast Cancer Stage
Unknown
0 Participants
n=45 Participants
1 Participants
n=12929 Participants
1 Participants
n=6349 Participants
Breast Cancer Stage
IIIB
14 Participants
n=45 Participants
3 Participants
n=12929 Participants
17 Participants
n=6349 Participants
Breast Cancer Stage
IV
0 Participants
n=45 Participants
1 Participants
n=12929 Participants
1 Participants
n=6349 Participants

PRIMARY outcome

Timeframe: Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks.

Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR.

Outcome measures

Outcome measures
Measure
Arm A: Eribulin followed by AC
n=16 Participants
* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Arm B: AC followed by Eribulin
n=6 Participants
* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Pathologic Complete Response Rate
6.25 percentage of participants
Interval 0.66 to 22.22
0 percentage of participants
Interval 0.0 to 31.87

SECONDARY outcome

Timeframe: DFS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death.The DFS measurement duration is anticipated to last for at least 5 years.

Disease-free survival (DFS) is defined for the participants who undergo surgery, as the duration of time from surgery until ipsilateral local-regional, contralateral or distant invasive recurrence or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: TTF is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The TTF measurement duration is anticipated to last for at least 5 years.

Time to treatment failure (TTF) will be defined among all participants, as the duration of time from treatment initiation to a DFS event or progressive disease during preoperative therapy or treatment disease that is not surgically resectable; in the absence of an event, TTF will be censored at the date last know alive and free from recurrence or progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: OS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The OS measurement duration is anticipated to last for at least 5 years.

Overall Survival (OS) will be defined two ways: among patients who undergo surgery, as time from surgery until death from any cause; and among all patients, as the time from treatment initiation until death from any cause. Censoring will use the date last known alive.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such summed up to 20 weeks.

Residual cancer burden is calculated and then categorized based on level of residual disease after neoadjuvant therapy and several other factors as assessed by pathologists. This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III.(RCB category "Unknown" if unable to determine RCB or missing data.) The previous categories are in order of increasing severity of RCB. Measurement of residual breast cancer burden can predict survival after neoadjuvant chemotherapy.

Outcome measures

Outcome measures
Measure
Arm A: Eribulin followed by AC
n=16 Participants
* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Arm B: AC followed by Eribulin
n=6 Participants
* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Residual Cancer Burden (RCB)
RCB-0
6.25 percentage of participants
Interval 0.66 to 22.22
0 percentage of participants
Interval 0.0 to 31.87
Residual Cancer Burden (RCB)
RCB-I
12.5 percentage of participants
Interval 3.37 to 29.96
0 percentage of participants
Interval 0.0 to 31.87
Residual Cancer Burden (RCB)
RCB-II
25 percentage of participants
Interval 11.38 to 43.89
50 percentage of participants
Interval 20.09 to 79.91
Residual Cancer Burden (RCB)
RCB-III
56.25 percentage of participants
Interval 37.5 to 73.71
33.33 percentage of participants
Interval 9.26 to 66.68
Residual Cancer Burden (RCB)
Unknown
0 percentage of participants
Interval 0.0 to 13.4
16.67 percentage of participants
Interval 1.74 to 51.03

Adverse Events

Arm A: Eribulin followed by AC

Serious events: 5 serious events
Other events: 16 other events
Deaths: 1 deaths

Arm B: AC followed by Eribulin

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm A: Eribulin followed by AC
n=16 participants at risk
* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Arm B: AC followed by Eribulin
n=6 participants at risk
* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Blood and lymphatic system disorders
Anemia
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations
Lung infection
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Alanine aminotransferase increased
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Aspartate aminotransferase increased
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Neutrophil count decreased
25.0%
4/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Pneumonitis
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Other adverse events

Other adverse events
Measure
Arm A: Eribulin followed by AC
n=16 participants at risk
* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Arm B: AC followed by Eribulin
n=6 participants at risk
* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans Eribulin: administered IV for 4 cycles Adriamycin: administered IV with cyclophosphamide for 4 cycles Cyclophosphamide: administered IV with adriamycin for 4 cycles
Blood and lymphatic system disorders
Anemia
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Lymph node pain
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders
Palpitations
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders
Tinnitus
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders
Hearing impaired
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders
Vertigo
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders
Dry eye
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Constipation
37.5%
6/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Diarrhea
25.0%
4/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Dry mouth
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Flatulence
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Gastroesophageal reflux disease
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Gingival pain
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Hemorrhoids
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Mucositis oral
25.0%
4/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Nausea
62.5%
10/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
83.3%
5/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders
Vomiting
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders and administration site conditions
Edema limbs
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders and administration site conditions
Fatigue
93.8%
15/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
100.0%
6/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders and administration site conditions
Flu like symptoms
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders and administration site conditions
Pain
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders and administration site conditions
Fever
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders
Dizziness
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations
Papulopustular rash
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations
Sinusitis
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Alanine aminotransferase increased
37.5%
6/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
66.7%
4/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Alkaline phosphatase increased
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Aspartate aminotransferase increased
37.5%
6/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
66.7%
4/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Neutrophil count decreased
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations
Weight loss
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders
Dehydration
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders
Dysgeusia
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders
Headache
43.8%
7/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
66.7%
4/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
37.5%
6/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
50.0%
3/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders
Tremor
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders
Anxiety
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders
Depression
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders
Insomnia
18.8%
3/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Breast pain
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Pharyngolaryngeal pain
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Sore throat
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Hoarseness
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Postnasal drip
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
62.5%
10/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
66.7%
4/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Hyperhidrosis
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Photosensitivity
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
33.3%
2/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Palmar-plantar erythrodysesthesia syndrome
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was 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
Periorbital edema
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders
Hot flashes
12.5%
2/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders
Thromboembolic event
6.2%
1/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
0.00%
0/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders
Flushing
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders
Lymphedema
0.00%
0/16 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
16.7%
1/6 • All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Additional Information

Filipa Lynce, MD

Dana-Farber Cancer Institute

Phone: 617-632-4056

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place