Trial Outcomes & Findings for FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer (NCT NCT02839265)
NCT ID: NCT02839265
Last Updated: 2025-01-31
Results Overview
The primary endpoint is progression-free survival rate at four months (PFS4), defined as the rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\~4 months) after initiation of study therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
4 Months
Results posted on
2025-01-31
Participant Flow
The recruitment period spanned from July 2016 through 1/23/2020. All patients enrolled into the study were enrolled at Montefiore Medical Center.
33 patients signed informed consent however 29 patients were enrolled and randomized into the study.
Participant milestones
| Measure |
SBRT + FLT3 Ligand Immunotherapy
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
SBRT + FLT3 Ligand Immunotherapy
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Overall Study
Screen Failure
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Progression of SVC syndrome prior to treatment initiation
|
1
|
Baseline Characteristics
FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 Participants
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Age, Customized
<= 50 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
51-60
|
3 Participants
n=5 Participants
|
|
Age, Customized
61-70
|
9 Participants
n=5 Participants
|
|
Age, Customized
71-80
|
12 Participants
n=5 Participants
|
|
Age, Customized
>81
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 MonthsThe primary endpoint is progression-free survival rate at four months (PFS4), defined as the rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\~4 months) after initiation of study therapy.
Outcome measures
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 Participants
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Progression-Free Survival
|
14 Participants
|
SECONDARY outcome
Timeframe: 30 daysThe number of participants with evidence of DLTs will be tabulated. For the purposes of this study, a DLT will be defined as any grade 3-5 treatment-emergent adverse event toxicity, scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and occurring within 30 days after treatment with SBRT in combination with FLT3 ligand therapy (after the first treatment cycle). Asymptomatic laboratory abnormalities (eg: leukocytosis) that do not require intervention will not be counted as DLTs. For subjects who receive more than one "cycle" of SBRT and FLT3 ligand, only adverse events that occur after the first cycle will be scored as potential DLTs.
Outcome measures
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 Participants
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Dose Limiting Toxicities (DLTs)
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 27 months post-randomizationRadiographic Response will be scored using RECIST V1.1 criteria based on 1st post-treatment imaging to quantify objective measures of change in tumor burden. RECIST uses a max of 10 target lesions per patient to determine when tumors in cancer patients improve, stay the same, or worsen during treatment. RECIST will be used to quantify the percentage of patients demonstrating Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), as follows: CR - resolution of all target lesions to background levels PR - at least 30% decrease in sum of diameters of target lesions (noting baseline diameters) SD - neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD (noting smallest sum on study) PD - at least 20% increase in sum of diameters of target lesions (noting smallest sum on study); absolute increase of 5mm must be demonstrated; \>=1 new lesion is considered PD If no CT/PET at a specific timepoint = "Not Evaluable"
Outcome measures
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 Participants
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Radiographic Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response (CR)
|
0 Participants
|
|
Radiographic Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response (PR)
|
4 Participants
|
|
Radiographic Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease (SD)
|
8 Participants
|
|
Radiographic Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease (PD)
|
17 Participants
|
|
Radiographic Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Not Evaluable (NE)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 27 months post-randomizationRadiographic Response will be scored using PERCIST criteria based on the first PET imaging done. PERCIST is a set of rules that define when tumors in cancer patients improve, stay the same, or worsen during treatment, based on imaging data. PERCIST criteria will be used to quantify the percentage of patients demonstrating Complete Metabolic Response (CMR), Partial Metabolic Response (PMR), Stable Metabolic Disease (SMD), Progressive Metabolic Disease (PMD), or Not Evaluable (NE) as follows: CMR - complete resolution of 18F-FDG uptake, disappearance of all target lesions to background levels, no new 18F-FDG lesions PMR - reduction of a minimum of 30% in target measurable tumor 18F-FDG SUL peak, no increase \>30% in all lesions; no new lesions SMD - no CMR, PMR or PMD; no new lesions PMD - \>30% increase in 18F-FDG peak; OR visible increase in extent of tumor uptake; OR new 18F-FDG lesions If CT/PET was not done at a specific timepoint, result will be considered "Not Evaluable"
Outcome measures
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 Participants
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Radiographic Response Rate Based on PET Response Criteria in Solid Tumors (PERCIST)
Complete Metabolic Response (CMR)
|
0 Participants
|
|
Radiographic Response Rate Based on PET Response Criteria in Solid Tumors (PERCIST)
Partial Metabolic Response (PMR)
|
9 Participants
|
|
Radiographic Response Rate Based on PET Response Criteria in Solid Tumors (PERCIST)
Progressive Metabolic Disease (PMD)
|
11 Participants
|
|
Radiographic Response Rate Based on PET Response Criteria in Solid Tumors (PERCIST)
Not Evaluable
|
0 Participants
|
|
Radiographic Response Rate Based on PET Response Criteria in Solid Tumors (PERCIST)
Stable Metabolic Disease (SMD)
|
9 Participants
|
SECONDARY outcome
Timeframe: From date of treatment to date of death, up to 5 yearsOverall survival (OS) is defined as the percentage of patients alive at 5 years post-randomization. Data of subjects without a death record will be censored on the last known survival date.
Outcome measures
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 Participants
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Overall Survival (OS)
|
3 Participants
|
Adverse Events
SBRT + FLT3 Ligand Immunotherapy
Serious events: 23 serious events
Other events: 29 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 participants at risk
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.3%
3/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Cardiac disorders
Chest Pain
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Cardiac disorders
Sinus Tachycardia
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Non-Cardiac Chest Pain
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
13.8%
4/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Infections and infestations
Sepsis
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Cardiac disorders
Cardiac Arrest
|
10.3%
3/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Nervous system disorders
Stroke
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Disease Progression
|
37.9%
11/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
Other adverse events
| Measure |
SBRT + FLT3 Ligand Immunotherapy
n=29 participants at risk
Patients will be treated with stereotactic body radiotherapy (SBRT) to a single pulmonary or extrapulmonary lesion as well as FLT3 immunotherapy.
FLT3 Ligand Therapy (CDX-301)
* Daily subcutaneous injections of CDX-301 (75 ug/kg) will be administered for 5 days, beginning on the first day of SBRT.
* Additional cycles of SBRT (to distinct lesions) and CDX-301 may be administered every 2-4 months to subjects who demonstrate evidence of clinical benefit (lack of treatment-related toxicity and no disease progression).
* Study therapy will be discontinued in cases of treatment-related toxicity or disease progression.
FLT3 Ligand Therapy (CDX-301): See Arm 1 descriptions
Stereotactic Body Radiotherapy (SBRT): See Arm 1 descriptions
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
58.6%
17/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Fatigue
|
72.4%
21/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
58.6%
17/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.8%
4/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
17.2%
5/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
34.5%
10/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
24.1%
7/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
17.2%
5/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Fever
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Pain
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Nervous system disorders
Dizziness
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac Chest Pain
|
13.8%
4/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Renal and urinary disorders
Pain - Suprapubic
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Edema Limbs
|
10.3%
3/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Hemorrhage
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Chills
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Injection Site Reaction
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Eye disorders
Dry Eye
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Eye disorders
Blurred Vision
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
General disorders
Flu Like Symptoms
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Investigations
Weight Loss
|
3.4%
1/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
|
Nervous system disorders
Paresthesia
|
6.9%
2/29 • Patients were monitored for the onset of Adverse Events for 32 weeks following treatment. Patients were assessed for All-cause Mortality up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place