Trial Outcomes & Findings for A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC (NCT NCT02314364)
NCT ID: NCT02314364
Last Updated: 2025-12-16
Results Overview
Distant failures (DF) are defined as metastases outside areas that originally contained disease. The 1-year frequency of DF is defined as the percentage of patients that experienced a DF, respectively, over the course of one year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
1 year
Results posted on
2025-12-16
Participant Flow
Participant milestones
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiation Therapy (SBRT) With Protons or Photons
n=27 Participants
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
Age, Continuous
|
59 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 1 yearDistant failures (DF) are defined as metastases outside areas that originally contained disease. The 1-year frequency of DF is defined as the percentage of patients that experienced a DF, respectively, over the course of one year.
Outcome measures
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
n=27 Participants
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
1-year Frequency of Distant Failures (DF) After Stereotactic Body Radiation Therapy (SBRT)
|
19 percentage of participants
Interval 7.0 to 36.0
|
SECONDARY outcome
Timeframe: Up to 8.4 yearsAdverse events were graded according to Common Terminology Criteria for Adverse Events (CTCAE v4.0). Treatment-related toxicities are defined as adverse events assessed as related to SBRT.
Outcome measures
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
n=27 Participants
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
Percentage of Participants With Grade 3 or Higher Toxicities Related to Stereotactic Body Radiation Therapy (SBRT)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7.65 yearsProgression free survival is defined as the duration of time from the start of standard of care TKI (tyrosine kinase inhibitor) therapy until objective progressive disease or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
n=27 Participants
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
Median Progression Free Survival
|
23.4 months
Interval 14.0 to 53.0
|
SECONDARY outcome
Timeframe: Up to 8.4 yearsOverall survival is defined as the duration of time from the start of documented tyrosine kinase inhibitor (TKI) therapy to the time of death.
Outcome measures
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
n=27 Participants
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
Median Overall Survival
|
59.6 months
Interval 42.3 to
Too few events occurred to estimate the upper confidence limit for median overall survival.
|
SECONDARY outcome
Timeframe: 2 yearsOverall survival is defined as the duration of time from the start of documented tyrosine kinase inhibitor (TKI) therapy to the time of death. The 2-year overall survival is defined as the percentage of participants who were alive 2 years after the start of documented tyrosine kinase inhibitor (TKI) therapy.
Outcome measures
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
n=27 Participants
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
2-year Overall Survival
|
88 percentage of participants
Interval 68.0 to 96.0
|
SECONDARY outcome
Timeframe: 2 yearsLocal failure is defined as progressive disease in target lesions treated with SBRT. The 2-year LF rate is the percentage of participants who experienced local failure within 2 years of completing SBRT.
Outcome measures
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
n=27 Participants
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
2-year Local Failure (LF) of Lesions Treated With Stereotactic Body Radiation Therapy (SBRT)
|
11 percentage of participants
Interval 3.0 to 27.0
|
Adverse Events
Stereotactic body radiation therapy (SBRT) with protons or photons
Serious events: 0 serious events
Other events: 27 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stereotactic body radiation therapy (SBRT) with protons or photons
n=27 participants at risk
* SBRT dosage determined by treating physician
* Patients will continue to receive standard of care (SOC) tyrosine kinase inhibitors (TKI) in the intervals between SBRT courses, as well as after the completion of SBRT
* If there is more than one active site of cancer, additional site(s) will be treated with stereotactic treatment courses. The total duration of SBRT courses (from the first day of any SBRT course to the last day of any SBRT course) will not exceed 4 months.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
11.1%
3/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
3/27 • Up to 8.4 years
|
|
Nervous system disorders
Abducens nerve disorder
|
3.7%
1/27 • Up to 8.4 years
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
3/27 • Up to 8.4 years
|
|
Investigations
Alkaline phosphatase increased
|
3.7%
1/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.4%
2/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.5%
5/27 • Up to 8.4 years
|
|
Nervous system disorders
Amnesia
|
3.7%
1/27 • Up to 8.4 years
|
|
Blood and lymphatic system disorders
Anemia
|
7.4%
2/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
3/27 • Up to 8.4 years
|
|
Psychiatric disorders
Anxiety
|
14.8%
4/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
7.4%
2/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
2/27 • Up to 8.4 years
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.7%
11/27 • Up to 8.4 years
|
|
Investigations
Blood bilirubin increased
|
7.4%
2/27 • Up to 8.4 years
|
|
Eye disorders
Blurred vision
|
14.8%
4/27 • Up to 8.4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
7.4%
2/27 • Up to 8.4 years
|
|
Eye disorders
Cataract
|
11.1%
3/27 • Up to 8.4 years
|
|
Cardiac disorders
Chest pain - cardiac
|
3.7%
1/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
14.8%
4/27 • Up to 8.4 years
|
|
General disorders
Chills
|
18.5%
5/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
3.7%
1/27 • Up to 8.4 years
|
|
Psychiatric disorders
Confusion
|
11.1%
3/27 • Up to 8.4 years
|
|
Eye disorders
Conjunctivitis
|
7.4%
2/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Constipation
|
48.1%
13/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
51.9%
14/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
2/27 • Up to 8.4 years
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • Up to 8.4 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
7.4%
2/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Diarrhea
|
70.4%
19/27 • Up to 8.4 years
|
|
Nervous system disorders
Dizziness
|
25.9%
7/27 • Up to 8.4 years
|
|
Eye disorders
Dry eye
|
14.8%
4/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
44.4%
12/27 • Up to 8.4 years
|
|
Nervous system disorders
Dysgeusia
|
7.4%
2/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
3/27 • Up to 8.4 years
|
|
Nervous system disorders
Dysphasia
|
7.4%
2/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.4%
12/27 • Up to 8.4 years
|
|
Ear and labyrinth disorders
Ear pain
|
3.7%
1/27 • Up to 8.4 years
|
|
General disorders
Edema face
|
3.7%
1/27 • Up to 8.4 years
|
|
General disorders
Edema limbs
|
25.9%
7/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.4%
2/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.4%
2/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Esophageal pain
|
3.7%
1/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Esophagitis
|
7.4%
2/27 • Up to 8.4 years
|
|
Eye disorders
Alternating exophoria
|
3.7%
1/27 • Up to 8.4 years
|
|
Eye disorders
Dysconjugate gaze
|
3.7%
1/27 • Up to 8.4 years
|
|
Eye disorders
Eyelid function disorder
|
3.7%
1/27 • Up to 8.4 years
|
|
Injury, poisoning and procedural complications
Fall
|
18.5%
5/27 • Up to 8.4 years
|
|
General disorders
Fatigue
|
59.3%
16/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.7%
1/27 • Up to 8.4 years
|
|
General disorders
Fever
|
14.8%
4/27 • Up to 8.4 years
|
|
Eye disorders
Flashing lights
|
3.7%
1/27 • Up to 8.4 years
|
|
General disorders
Flu like symptoms
|
3.7%
1/27 • Up to 8.4 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.7%
1/27 • Up to 8.4 years
|
|
General disorders
Gait disturbance
|
25.9%
7/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.8%
4/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.4%
2/27 • Up to 8.4 years
|
|
Nervous system disorders
Headache
|
33.3%
9/27 • Up to 8.4 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.4%
2/27 • Up to 8.4 years
|
|
Renal and urinary disorders
Hematuria
|
3.7%
1/27 • Up to 8.4 years
|
|
Infections and infestations
Hepatitis viral
|
3.7%
1/27 • Up to 8.4 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.7%
1/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.7%
1/27 • Up to 8.4 years
|
|
Vascular disorders
Hot flashes
|
3.7%
1/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.8%
4/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.4%
2/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
1/27 • Up to 8.4 years
|
|
Nervous system disorders
Hypersomnia
|
3.7%
1/27 • Up to 8.4 years
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.7%
1/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.7%
1/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.4%
2/27 • Up to 8.4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
3/27 • Up to 8.4 years
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Up to 8.4 years
|
|
Endocrine disorders
Hypothyroidism
|
7.4%
2/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Up to 8.4 years
|
|
Psychiatric disorders
Insomnia
|
25.9%
7/27 • Up to 8.4 years
|
|
Investigations
Increased neutrophils
|
3.7%
1/27 • Up to 8.4 years
|
|
Infections and infestations
Laryngitis
|
3.7%
1/27 • Up to 8.4 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.7%
1/27 • Up to 8.4 years
|
|
Investigations
Lipase increased
|
3.7%
1/27 • Up to 8.4 years
|
|
General disorders
Localized edema
|
7.4%
2/27 • Up to 8.4 years
|
|
Infections and infestations
Lymph gland infection
|
3.7%
1/27 • Up to 8.4 years
|
|
Investigations
Lymphocyte count decreased
|
44.4%
12/27 • Up to 8.4 years
|
|
General disorders
Malaise
|
7.4%
2/27 • Up to 8.4 years
|
|
Nervous system disorders
Memory impairment
|
11.1%
3/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
3.7%
1/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
11.1%
3/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
3.7%
1/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
3.7%
1/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Lower left extremity numbness
|
3.7%
1/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
3.7%
1/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
1/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Nausea
|
44.4%
12/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
1/27 • Up to 8.4 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
11.1%
3/27 • Up to 8.4 years
|
|
General disorders
Non-cardiac chest pain
|
18.5%
5/27 • Up to 8.4 years
|
|
Nervous system disorders
Oculomotor nerve disorder
|
3.7%
1/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Oral pain
|
3.7%
1/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.7%
1/27 • Up to 8.4 years
|
|
General disorders
Pain
|
33.3%
9/27 • Up to 8.4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.8%
4/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.7%
1/27 • Up to 8.4 years
|
|
Cardiac disorders
Palpitations
|
11.1%
3/27 • Up to 8.4 years
|
|
Infections and infestations
Papulopustular rash
|
3.7%
1/27 • Up to 8.4 years
|
|
Nervous system disorders
Paresthesia
|
11.1%
3/27 • Up to 8.4 years
|
|
Infections and infestations
Paronychia
|
25.9%
7/27 • Up to 8.4 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.7%
1/27 • Up to 8.4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
3/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
3.7%
1/27 • Up to 8.4 years
|
|
Investigations
Platelet count decreased
|
7.4%
2/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.4%
2/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
22.2%
6/27 • Up to 8.4 years
|
|
Nervous system disorders
Presyncope
|
7.4%
2/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
22.2%
6/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
3.7%
1/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
9/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.5%
5/27 • Up to 8.4 years
|
|
Infections and infestations
Rash pustular
|
3.7%
1/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.7%
1/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Rectal perforation
|
3.7%
1/27 • Up to 8.4 years
|
|
Renal and urinary disorders
neurogenic sensory cystopathy
|
3.7%
1/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.7%
1/27 • Up to 8.4 years
|
|
Infections and infestations
Rhinitis infective
|
3.7%
1/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.7%
1/27 • Up to 8.4 years
|
|
Nervous system disorders
Seizure
|
3.7%
1/27 • Up to 8.4 years
|
|
Investigations
Serum amylase increased
|
3.7%
1/27 • Up to 8.4 years
|
|
Immune system disorders
Serum sickness
|
3.7%
1/27 • Up to 8.4 years
|
|
Cardiac disorders
Sinus tachycardia
|
7.4%
2/27 • Up to 8.4 years
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
1/27 • Up to 8.4 years
|
|
Infections and infestations
Skin infection
|
7.4%
2/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Dermatoheliosis
|
3.7%
1/27 • Up to 8.4 years
|
|
Skin and subcutaneous tissue disorders
Cracking of fingernails
|
3.7%
1/27 • Up to 8.4 years
|
|
Infections and infestations
Soft tissue infection
|
3.7%
1/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.7%
1/27 • Up to 8.4 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.7%
1/27 • Up to 8.4 years
|
|
Vascular disorders
Thromboembolic event
|
3.7%
1/27 • Up to 8.4 years
|
|
Ear and labyrinth disorders
Tinnitus
|
7.4%
2/27 • Up to 8.4 years
|
|
Nervous system disorders
Transient ischemic attacks
|
3.7%
1/27 • Up to 8.4 years
|
|
Nervous system disorders
Tremor
|
7.4%
2/27 • Up to 8.4 years
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
3/27 • Up to 8.4 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.7%
1/27 • Up to 8.4 years
|
|
Renal and urinary disorders
Urinary incontinence
|
3.7%
1/27 • Up to 8.4 years
|
|
Renal and urinary disorders
Urinary retention
|
7.4%
2/27 • Up to 8.4 years
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Up to 8.4 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.7%
1/27 • Up to 8.4 years
|
|
Renal and urinary disorders
Urinary urgency
|
3.7%
1/27 • Up to 8.4 years
|
|
Vascular disorders
Orthostatic hypotension
|
3.7%
1/27 • Up to 8.4 years
|
|
Ear and labyrinth disorders
Vertigo
|
7.4%
2/27 • Up to 8.4 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
3/27 • Up to 8.4 years
|
|
Eye disorders
Watering eyes
|
7.4%
2/27 • Up to 8.4 years
|
|
Investigations
Weight gain
|
7.4%
2/27 • Up to 8.4 years
|
|
Investigations
Weight loss
|
3.7%
1/27 • Up to 8.4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.4%
2/27 • Up to 8.4 years
|
|
Investigations
White blood cell decreased
|
25.9%
7/27 • Up to 8.4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place