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.
ACTIVE_NOT_RECRUITING
PHASE2
22 participants
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.
2025-11-25
Participant Flow
February 2016 to December 2020
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
| 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
| 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
| 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
Arm B: AC followed by Eribulin
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place