Trial Outcomes & Findings for Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial (NCT NCT02045446)
NCT ID: NCT02045446
Last Updated: 2023-05-23
Results Overview
Evaluate the effect of SBRT with maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival. Time to the development of new lesions, progression of existing lesions, or death, whichever came first, represented the primary end point of progression-free survival. All evaluations of disease response used RECIST (v1.1) criteria, in which progressive disease is defined as "At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
5 years
Results posted on
2023-05-23
Participant Flow
Participant milestones
| Measure |
Maintenance Chemotherapy
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Maintenance Chemotherapy
n=15 Participants
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 Participants
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
70.0 years
n=15 Participants
|
63.5 years
n=14 Participants
|
66 years
n=29 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
5 Participants
n=14 Participants
|
9 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
9 Participants
n=14 Participants
|
20 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
29 Participants
n=29 Participants
|
|
Histology
Squamous
|
3 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
4 Participants
n=29 Participants
|
|
Histology
Nonsquamous
|
12 Participants
n=15 Participants
|
13 Participants
n=14 Participants
|
25 Participants
n=29 Participants
|
|
Sites of disease prior to induction chemotherapy
|
2 sites of disease
n=15 Participants
|
3 sites of disease
n=14 Participants
|
3 sites of disease
n=29 Participants
|
|
Previously treated brain metastases
Yes
|
5 Participants
n=15 Participants
|
6 Participants
n=14 Participants
|
11 Participants
n=29 Participants
|
|
Previously treated brain metastases
No
|
10 Participants
n=15 Participants
|
8 Participants
n=14 Participants
|
18 Participants
n=29 Participants
|
|
Induction chemotherapy, median cycles
|
4 cycles
n=15 Participants
|
4.5 cycles
n=14 Participants
|
4 cycles
n=29 Participants
|
PRIMARY outcome
Timeframe: 5 yearsEvaluate the effect of SBRT with maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival. Time to the development of new lesions, progression of existing lesions, or death, whichever came first, represented the primary end point of progression-free survival. All evaluations of disease response used RECIST (v1.1) criteria, in which progressive disease is defined as "At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
Outcome measures
| Measure |
Maintenance Chemotherapy
n=15 Participants
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 Participants
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
Progression Free Survival
|
3.5 months
Interval 3.387 to 4.315
|
9.7 months
Interval 9.587 to 10.515
|
SECONDARY outcome
Timeframe: 5 yearsNumber of occurances of in-field local control and rate of out-of-field disease progression
Outcome measures
| Measure |
Maintenance Chemotherapy
n=15 Participants
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 Participants
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
In-field Local Control Versus Out-of-field Disease Progression
Progression in brain
|
4 Patients
|
1 Patients
|
|
In-field Local Control Versus Out-of-field Disease Progression
Progression in liver
|
0 Patients
|
2 Patients
|
|
In-field Local Control Versus Out-of-field Disease Progression
Progression in lung
|
8 Patients
|
0 Patients
|
|
In-field Local Control Versus Out-of-field Disease Progression
Progression in bone
|
1 Patients
|
1 Patients
|
|
In-field Local Control Versus Out-of-field Disease Progression
Progression in pancreas
|
0 Patients
|
1 Patients
|
|
In-field Local Control Versus Out-of-field Disease Progression
In-field progression
|
7 Patients
|
0 Patients
|
SECONDARY outcome
Timeframe: 2 yearsTo evaluate the safety of SBRT with metastatic NSCLC after prior chemotherapy
Outcome measures
| Measure |
Maintenance Chemotherapy
n=15 Participants
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 Participants
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
Toxicities
Grade 3 toxicities probably or definitely attributed to study
|
2 adverse events
|
4 adverse events
|
|
Toxicities
Grade 4 toxicities probably or definitely attributed to study
|
1 adverse events
|
0 adverse events
|
|
Toxicities
Grade 5 toxicities probably or definitely attributed to study
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: 5 yearsTo evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.
Outcome measures
| Measure |
Maintenance Chemotherapy
n=15 Participants
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 Participants
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
Overall Survival
|
189 days
Interval 28.0 to 587.0
|
203.5 days
Interval 5.0 to 679.0
|
SECONDARY outcome
Timeframe: 5 yearsTo evaluate the duration of maintenance chemotherapy and time to initiation of third line systemic agent (chemotherapy or biologic agent)
Outcome measures
| Measure |
Maintenance Chemotherapy
n=15 Participants
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 Participants
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
Duration of Maintenance Chemotherapy
|
3 cycles
Interval 1.0 to 15.0
|
5 cycles
Interval 3.0 to 19.0
|
Adverse Events
Maintenance Chemotherapy
Serious events: 6 serious events
Other events: 15 other events
Deaths: 3 deaths
Stereotactic Body Radiation Therapy
Serious events: 8 serious events
Other events: 14 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Maintenance Chemotherapy
n=15 participants at risk
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 participants at risk
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Infections and infestations
Skin infection
|
13.3%
2/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 3 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Number of events 2 • 5 years
|
21.4%
3/14 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
13.3%
2/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
General disorders
Headaches
|
6.7%
1/15 • Number of events 3 • 5 years
|
0.00%
0/14 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic respiratory failure
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
General disorders
Death NOS
|
6.7%
1/15 • Number of events 1 • 5 years
|
21.4%
3/14 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
General disorders
Fatigue
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
General disorders
Back pain
|
0.00%
0/15 • 5 years
|
14.3%
2/14 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Maintenance Chemotherapy
n=15 participants at risk
FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed
Maintenance chemotherapy: Maintenance chemotherapy
|
Stereotactic Body Radiation Therapy
n=14 participants at risk
Consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy
Stereotactic Body Radiation Therapy
Maintenance chemotherapy: Maintenance chemotherapy
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Immune system disorders
Allergy (seasonal)
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Nervous system disorders
Amnesia
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
26.7%
4/15 • Number of events 4 • 5 years
|
28.6%
4/14 • Number of events 7 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • 5 years
|
21.4%
3/14 • Number of events 3 • 5 years
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • 5 years
|
21.4%
3/14 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 3 • 5 years
|
28.6%
4/14 • Number of events 5 • 5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
General disorders
Chest pain
|
20.0%
3/15 • Number of events 4 • 5 years
|
21.4%
3/14 • Number of events 4 • 5 years
|
|
General disorders
Chills
|
20.0%
3/15 • Number of events 3 • 5 years
|
0.00%
0/14 • 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • 5 years
|
42.9%
6/14 • Number of events 8 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
5/15 • Number of events 7 • 5 years
|
78.6%
11/14 • Number of events 16 • 5 years
|
|
Investigations
Creatinine increased
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Delirium
|
13.3%
2/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
Psychiatric disorders
Depression
|
26.7%
4/15 • Number of events 5 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • Number of events 3 • 5 years
|
35.7%
5/14 • Number of events 5 • 5 years
|
|
Nervous system disorders
Dysesthesia
|
13.3%
2/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
13.3%
2/15 • Number of events 2 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
4/15 • Number of events 5 • 5 years
|
64.3%
9/14 • Number of events 15 • 5 years
|
|
General disorders
Edema
|
13.3%
2/15 • Number of events 2 • 5 years
|
14.3%
2/14 • Number of events 3 • 5 years
|
|
General disorders
Edema limbs
|
20.0%
3/15 • Number of events 3 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multitforme
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
26.7%
4/15 • Number of events 4 • 5 years
|
21.4%
3/14 • Number of events 3 • 5 years
|
|
General disorders
Fatigue
|
86.7%
13/15 • Number of events 17 • 5 years
|
57.1%
8/14 • Number of events 13 • 5 years
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
General disorders
Gait disturbance
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • 5 years
|
14.3%
2/14 • Number of events 3 • 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Hearing loss
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Immune system disorders
Shingles
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Infections and infestations
Oral lesions
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Number of events 2 • 5 years
|
14.3%
2/14 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Low white blood count
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
26.7%
4/15 • Number of events 5 • 5 years
|
21.4%
3/14 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • Number of events 3 • 5 years
|
0.00%
0/14 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • Number of events 9 • 5 years
|
64.3%
9/14 • Number of events 10 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
3/15 • Number of events 4 • 5 years
|
0.00%
0/14 • 5 years
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
General disorders
Pain
|
26.7%
4/15 • Number of events 6 • 5 years
|
35.7%
5/14 • Number of events 8 • 5 years
|
|
Nervous system disorders
Parathesia (tingling)
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Eye disorders
Photophobia
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Investigations
Platelet count decreased
|
26.7%
4/15 • Number of events 4 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Number of events 2 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Nervous system disorders
Seizures
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Infections and infestations
Skin infection
|
13.3%
2/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
13.3%
2/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • 5 years
|
28.6%
4/14 • Number of events 5 • 5 years
|
|
General disorders
Weakness (facial)
|
6.7%
1/15 • Number of events 1 • 5 years
|
0.00%
0/14 • 5 years
|
|
General disorders
Weakness (limb)
|
13.3%
2/15 • Number of events 2 • 5 years
|
0.00%
0/14 • 5 years
|
|
Investigations
Weight loss
|
13.3%
2/15 • Number of events 2 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Investigations
Thrombocytopenia
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Eye disorders
Floaters
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 2 • 5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • 5 years
|
14.3%
2/14 • Number of events 5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Infections and infestations
Otitis externa
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
General disorders
Edema face
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Bone marrow biopsy
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/15 • 5 years
|
14.3%
2/14 • Number of events 3 • 5 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • 5 years
|
14.3%
2/14 • Number of events 2 • 5 years
|
|
Eye disorders
Eye pain
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Throat pain
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Dementia
|
0.00%
0/15 • 5 years
|
7.1%
1/14 • Number of events 1 • 5 years
|
Additional Information
Dr. Puneeth Iyengar
University of Texas Southwestern Medical Center
Phone: 214/645-7603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place