Trial Outcomes & Findings for Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy (NCT NCT03872388)
NCT ID: NCT03872388
Last Updated: 2024-10-02
Results Overview
Estimate the proportion of patients with undetectable circulating tumor cells (CTCs) at 6 months in patients with stage IIB/III TNBC who did not achieve a pCR or Residual Cancer Burden-I (RCB-I) after receiving neoadjuvant chemotherapy (NAC) with and without atorvastatin therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
At 6 months
Results posted on
2024-10-02
Participant Flow
September 2019- May 2022. All recruitment was done at The University of Texas MD Anderson Cancer Center.
6 participants were accrued and assessed for eligibility and 4 patients were assigned to the cohort.
Participant milestones
| Measure |
Cohort 1a
Atorvastatin treatment starting at the beginning of radiation. No xeloda.
|
Cohort 1b
No Atorvastatin treatment, assessment before starting radiation, no xeloda.
|
Cohort 2a
Atorvastatin treatment after xeloda but starting concurrently with radiation.
|
Cohort 2b
No atorvastatin treatment, assessment after xeloda but prior to radiation.
|
Cohort 3a
Atorvastatin treatment after radiation and xeloda are complete, with optional pre-xeloda blood draw.
|
Cohort 3b
No atorvastatin treatment, assessment after radiation and xeloda are complete, with optional pre-xeloda timepoint
|
Cohort 4a
Atorvastatin treatment, after xeloda +/- radiation, enrolled after all other therapies are complete.
|
Cohort 4b
No atorvastatin treatment, assessment after xeloda +/- radiation, enrolled after all other therapies are complete.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1a
Atorvastatin treatment starting at the beginning of radiation. No xeloda.
|
Cohort 1b
No Atorvastatin treatment, assessment before starting radiation, no xeloda.
|
Cohort 2a
Atorvastatin treatment after xeloda but starting concurrently with radiation.
|
Cohort 2b
No atorvastatin treatment, assessment after xeloda but prior to radiation.
|
Cohort 3a
Atorvastatin treatment after radiation and xeloda are complete, with optional pre-xeloda blood draw.
|
Cohort 3b
No atorvastatin treatment, assessment after radiation and xeloda are complete, with optional pre-xeloda timepoint
|
Cohort 4a
Atorvastatin treatment, after xeloda +/- radiation, enrolled after all other therapies are complete.
|
Cohort 4b
No atorvastatin treatment, assessment after xeloda +/- radiation, enrolled after all other therapies are complete.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy
Baseline characteristics by cohort
| Measure |
Cohort 1a
Atorvastatin treatment starting at the beginning of radiation. No xeloda.
|
Cohort 1b
No Atorvastatin treatment, assessment before starting radiation, no xeloda.
|
Cohort 2a
Atorvastatin treatment after xeloda but starting concurrently with radiation.
|
Cohort 2b
No atorvastatin treatment, assessment after xeloda but prior to radiation.
|
Cohort 3a
Atorvastatin treatment after radiation and xeloda are complete, with optional pre-xeloda blood draw.
|
Cohort 3b
No atorvastatin treatment, assessment after radiation and xeloda are complete, with optional pre-xeloda timepoint
|
Cohort 4a
n=2 Participants
Atorvastatin treatment, after xeloda +/- radiation, enrolled after all other therapies are complete.
|
Cohort 4b
n=2 Participants
No atorvastatin treatment, assessment after xeloda +/- radiation, enrolled after all other therapies are complete.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
—
|
—
|
—
|
—
|
2 participants
n=8 Participants
|
2 participants
n=24 Participants
|
4 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Data were not collected.
Estimate the proportion of patients with undetectable circulating tumor cells (CTCs) at 6 months in patients with stage IIB/III TNBC who did not achieve a pCR or Residual Cancer Burden-I (RCB-I) after receiving neoadjuvant chemotherapy (NAC) with and without atorvastatin therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Data were not collected.
Determine if baseline fasting lipid profile level (LDL-C) and/or change in serum lipid levels are a predictive biomarker of change in the proportion of patients with CTCs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data were not collected.
Assess effect of biomarkers on atorvastatin treatment response, defined as CTCs, circulating tumor DNA (ctDNA), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), serum Interleukin-6 (IL-6) and other inflammatory cytokines, for the purpose of identifying the optimal patient population for future larger scale adjuvant studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Data were not collected.
Fasting lipid profile level (LDL-C) and 2-year RFS rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Data were not collected.
Determine if baseline CRP and/or change in serum lipid levels are a predictive biomarker of change in the proportion of patients with CTCs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Data were not collected.
Determine if baseline absolute number of CTCs and/or CTC change are associated with 2-year RFS rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 2 yearsPopulation: Data were not collected.
Estimate the 2-year RFS rate of patients with TNBC who did not achieve pCR with and without atorvastatin therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Only 1 patient who was treated with atorvastatin came for any follow up appointments, however she missed the 6 month timepoint which is the primary end-point of the study. Therefore she was deemed inevaluable. One other treated patient started treatment and died before the 3 month follow up visit, and hence no data was obtained on any patients for cohort 1-3.
Adverse events, grade and relationship will be tabulated by treatment arms.
Outcome measures
| Measure |
Cohort 1a
Atorvastatin treatment starting at the beginning of radiation. No xeloda.
|
Cohort 1b
No Atorvastatin treatment, assessment before starting radiation, no xeloda.
|
Cohort 2a
Atorvastatin treatment after xeloda but starting concurrently with radiation.
|
Cohort 2b
No atorvastatin treatment, assessment after xeloda but prior to radiation.
|
Cohort 3a
Atorvastatin treatment after radiation and xeloda are complete, with optional pre-xeloda blood draw.
|
Cohort 3b
No atorvastatin treatment, assessment after radiation and xeloda are complete, with optional pre-xeloda timepoint
|
Cohort 4a
n=2 Participants
Atorvastatin treatment, after xeloda +/- radiation, enrolled after all other therapies are complete.
|
Cohort 4b
n=2 Participants
No atorvastatin treatment, assessment after xeloda +/- radiation, enrolled after all other therapies are complete.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Adverse Events
Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
4 events
|
12 events
|
|
Incidence of Adverse Events
Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
0 events
|
3 events
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Data were not collected.
Determine if baseline C-reactive protein (CRP) and/or change in CRP are associated with 2-year RFS rate.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1b
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2b
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3b
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4a
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 4b
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1a
Atorvastatin treatment starting at the beginning of radiation. No xeloda.
|
Cohort 1b
No Atorvastatin treatment, assessment before starting radiation, no xeloda.
|
Cohort 2a
Atorvastatin treatment after xeloda but starting concurrently with radiation.
|
Cohort 2b
No atorvastatin treatment, assessment after xeloda but prior to radiation.
|
Cohort 3a
Atorvastatin treatment after radiation and xeloda are complete, with optional pre-xeloda blood draw.
|
Cohort 3b
No atorvastatin treatment, assessment after radiation and xeloda are complete, with optional pre-xeloda timepoint
|
Cohort 4a
n=2 participants at risk
Atorvastatin treatment, after xeloda +/- radiation, enrolled after all other therapies are complete.
|
Cohort 4b
n=2 participants at risk
No atorvastatin treatment, assessment after xeloda +/- radiation, enrolled after all other therapies are complete.
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Reproductive system and breast disorders
Breast pain
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Cardiac disorders
Heart rate increased
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Infections and infestations
Conjunctivitis infective
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
General disorders
Gait disturbance
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Nervous system disorders
Headache
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Vascular disorders
Hypertension
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Vascular disorders
Lymphedema
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
General disorders
Pain
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Cardiac disorders
Palpitations
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Infections and infestations
Skin infection
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
—
0/0 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
0.00%
0/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
50.0%
1/2 • Serious adverse events (SAEs) were captured from the time the patient signs consent until 24 months follow-up was completed or the patient's disease progressed.
All SAEs, expected or unexpected regardless of attribution. The NCI-CTC version 4.0 will be used to grade all AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place