Trial Outcomes & Findings for Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer (NCT NCT04081389)
NCT ID: NCT04081389
Last Updated: 2023-09-11
Results Overview
Safety and toxicity will be assessed using the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). The resulting dose limiting toxicity (DLT) information is used to identify the appropriate dose level of CKM and paclitaxel for future clinical exploration. The following events will be considered a DLT: * The event occurs within 3 weeks following 1st dose of combination CKM + paclitaxel therapy and subsequent enrollment for dose-escalation will only proceed after the 3-week period has been completed. * The toxicity has been determined by the investigator to be possibly, probably or definitely related to celecoxib, rintatolimod, interferon-α2b or paclitaxel. * Any death not clearly due to th
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Within 21 days of treatment adminstration
Results posted on
2023-09-11
Participant Flow
Participant milestones
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
4
|
3
|
|
Overall Study
COMPLETED
|
1
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 Participants
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 Participants
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=4 Participants
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 Participants
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 0 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 0 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
47.6 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Overall American Joint Committee on Cancer (AJCC) Stage
Stage I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Overall American Joint Committee on Cancer (AJCC) Stage
Stage II
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Overall American Joint Committee on Cancer (AJCC) Stage
Stage III
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Laterality
Right Breast
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Laterality
Left Breast
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 21 days of treatment adminstrationPopulation: 1 patient was not DLT evaluable in DL3.
Safety and toxicity will be assessed using the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). The resulting dose limiting toxicity (DLT) information is used to identify the appropriate dose level of CKM and paclitaxel for future clinical exploration. The following events will be considered a DLT: * The event occurs within 3 weeks following 1st dose of combination CKM + paclitaxel therapy and subsequent enrollment for dose-escalation will only proceed after the 3-week period has been completed. * The toxicity has been determined by the investigator to be possibly, probably or definitely related to celecoxib, rintatolimod, interferon-α2b or paclitaxel. * Any death not clearly due to th
Outcome measures
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 Participants
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 Participants
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=3 Participants
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 Participants
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 week post-treatment (with a range of 7 to 11 weeks).Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, where Complete Response (CR) corresponds to the disappearance of all target lesions.
Outcome measures
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 Participants
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 Participants
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=4 Participants
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 Participants
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Number of Patients With Pathological Complete Response (pCR)
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 12 weeks post treatment initiation.The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis.
Outcome measures
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 Participants
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 Participants
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=4 Participants
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 Participants
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Residual Cancer Burden Index
RCB-0
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Residual Cancer Burden Index
RCB-I
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Residual Cancer Burden Index
RCB-II
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 3 yearsRFS is defined as local/regional invasive recurrence, invasive ipsilateral breast tumor recurrence, distant recurrence, inoperable (meaning no surgery because of progression), and/or death from breast cancer (per standard of care according to physician discretion) or any cause. RFS will be calculated from the time of treatment to event. The median RFS was estimated using standard Kaplan-Meier methods (where NR = not reached).
Outcome measures
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 Participants
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 Participants
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=4 Participants
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 Participants
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Recurrence-free Survival (RFS)
|
12.0 months
Unable to estimate the upper and lower bounds by the Kaplan-Meier method due to the number of observations (n=1).
|
NA months
No events observed, cannot estimate the median and corresponding bounds.
|
11.4 months
Interval 6.1 to 11.7
|
11.5 months
Interval 11.4 to
Unable to estimate the upper bound by the Kaplan-Meier method due to the limited number of events.
|
SECONDARY outcome
Timeframe: At 3 yearsOS is defined by death from breast cancer, non-breast cancer, unknown, or any other cause and will be calculated from the time of study entry to event. The median OS is estimated using standard Kaplan-Meier methods (where NR = not reached).
Outcome measures
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 Participants
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 Participants
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=4 Participants
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 Participants
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
21.7 months
Unable to estimate the upper and lower bounds by the Kaplan-Meier method due to a sample size of n=1.
|
NA months
No events observed, cannot estimate the median and corresponding bounds.
|
NA months
Interval 23.8 to
Unable to estimate the upper bound by the Kaplan-Meier method due to the limited number of events.
|
NA months
No events observed, cannot estimate the median and corresponding bounds.
|
Adverse Events
Arm 1: Interferon Alpha-2b at DL 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm 2: Interferon Alpha-2b at DL 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3: Interferon Alpha-2b at DL 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm 4: Interferon Alpha-2b at DL 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 participants at risk
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 participants at risk
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=4 participants at risk
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 participants at risk
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
Other adverse events
| Measure |
Arm 1: Interferon Alpha-2b at DL 1
n=1 participants at risk
Dose Level 1
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: None
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 2: Interferon Alpha-2b at DL 2
n=1 participants at risk
Dose Level 2
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 5 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 3: Interferon Alpha-2b at DL 3
n=4 participants at risk
Dose Level 3
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 10 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
Arm 4: Interferon Alpha-2b at DL 4
n=3 participants at risk
Dose Level 4
Celecoxib: 200 mg orally BID on days 1-3 of weeks 1-3.
Interferon alpha-2b: 20 million units/m2 IV on days 1-3 of weeks 1-3.
Rintatolimod: 200 mg intravenous on days 1-3 of weeks 1-3.
Paclitaxel: 80 mg/m2 intravenous once weekly on day 1
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
75.0%
3/4 • Number of events 5 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
4/4 • Number of events 4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Psychiatric disorders
Anxiety
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Eye disorders
Blurred vision
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
General disorders
Chills
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 6 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Psychiatric disorders
Depression
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
75.0%
3/4 • Number of events 5 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 5 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
General disorders
Edema limbs
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Eye disorders
Eye pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
75.0%
3/4 • Number of events 6 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
3/3 • Number of events 6 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
75.0%
3/4 • Number of events 6 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
75.0%
3/4 • Number of events 5 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 5 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
75.0%
3/4 • Number of events 7 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
3/3 • Number of events 6 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
75.0%
3/4 • Number of events 10 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
General disorders
Pain
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
1/1 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
4/4 • Number of events 5 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Stomach pain
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Eye disorders
Vision decreased
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Eye disorders
Watering eyes
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
66.7%
2/3 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
General disorders
Fever
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 3 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
General disorders
Malaise
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
0.00%
0/4 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 30 days after the final treatment administration (ranging from 7 to 11 weeks). All-cause mortality was monitored up to 3 years after treatment initiation.
Grading scales found in the CTEP Version 5 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|
Additional Information
Kristopher Attwood
Roswell Park Comprehensive Cancer Center
Phone: 716-845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place