Trial Outcomes & Findings for A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung (NCT NCT00752206)
NCT ID: NCT00752206
Last Updated: 2020-01-18
Results Overview
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Evaluation for recurrence/progression will be made every 3 months for the 1st year, then every 6 months up to 2 years, then every year up to 5 years after starting treatment.
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
Saracatinib
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
Placebo
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
Saracatinib
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
Placebo
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Overall Study
Disease progression
|
8
|
11
|
|
Overall Study
Pregnancy
|
1
|
0
|
Baseline Characteristics
38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
Baseline characteristics by cohort
| Measure |
Saracatinib
n=18 Participants
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
n=19 Participants
Placebo
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
23.89 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
26.63 years
STANDARD_DEVIATION 12.07 • n=7 Participants
|
25.30 years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Histology types
Osteoblastic sub-type
|
9 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
12 Participants
n=7 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
21 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
|
Histology types
Chondroblastic
|
6 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
3 Participants
n=7 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
9 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
|
Histology types
Telangiectatic
|
3 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
1 Participants
n=7 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
4 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
|
Histology types
Fibroblastic
|
0 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
3 Participants
n=7 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
3 Participants
n=5 Participants • 38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.
|
PRIMARY outcome
Timeframe: Evaluation for recurrence/progression will be made every 3 months for the 1st year, then every 6 months up to 2 years, then every year up to 5 years after starting treatment.Population: 38 subjects were randomized to receive therapy. One randomized subject was subsequently taken off-study for pregnancy; therefore 37 subjects were included in the analysis.
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival.
Outcome measures
| Measure |
Saracatinib
n=18 Participants
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
n=19 Participants
Placebo
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo.
|
19.4 months
Interval 0.0 to 60.0
|
8.6 months
Interval 0.0 to 60.0
|
SECONDARY outcome
Timeframe: 5 year overall survivalTo determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in overall survival.
Outcome measures
| Measure |
Saracatinib
n=18 Participants
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
n=19 Participants
Placebo
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy
|
NA months
Interval 45.0 to 70.0
Median overall survival (OS) not reached in either group and the curves overlapped.
|
NA months
Interval 45.0 to 70.0
Median overall survival (OS) not reached in either group and the curves overlapped.
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Did not perform time to progression analysis, but rather evaluated PFS. There was no data to report for time to treatment failure.
To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in the time to treatment failure. Time to treatment failure is the time from randomization to treatment discontinuation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsTo perform microarray analysis of tumor samples to identify a gene signature that predicts for recurrence of osteosarcoma using methodology that relies on preparation of RNA, followed by cDNA. Fluorescent labeling followed by hybridization to a DNA chip allows for quantitative scanning for hybridized complexes.
Outcome measures
| Measure |
Saracatinib
n=18 Participants
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
n=19 Participants
Placebo
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Number of Genes Identified for Prediction of Recurrence of Osteosarcoma
|
0 identified genes
|
0 identified genes
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: This testing was not performed.
To evaluate tumor samples for biomarkers related to activation of Src and Src substrates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: This testing was not performed.
To establish cell lines and murine xenografts from recurrent tumor samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsTo perform sequencing analysis of DNA and RNA in tumor samples compared to normal blood to detect mutations that may be causative for recurrent osteosarcoma. The methodology uses transcriptome sequencing, exon re-sequencing and mate-pair end sequencing, allowing us to detect translocations. The availability of matched normal DNA in the blood will allow us to determine which changes are unique to the tumor.
Outcome measures
| Measure |
Saracatinib
n=18 Participants
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
n=19 Participants
Placebo
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Number of Mutations Identified That May be Causative For Recurrent Osteosarcoma
|
0 identified mutations
|
0 identified mutations
|
Adverse Events
Saracatinib
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saracatinib
n=37 participants at risk；n=18 participants at risk
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
n=37 participants at risk；n=19 participants at risk
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung Nodules
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma Multiforme
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Mass
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
Other adverse events
| Measure |
Saracatinib
n=37 participants at risk；n=18 participants at risk
Saracatinib: Oral Agent
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
Placebo
n=37 participants at risk；n=19 participants at risk
Administered once daily, oral dose of 175 mg for a 28 day cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
3/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.1%
2/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Investigations
Alanine Aminotransferase increased
|
16.7%
3/18 • 5 years
|
15.8%
3/19 • 5 years
|
|
Investigations
Alkaline Phosphatase increased
|
22.2%
4/18 • 5 years
|
15.8%
3/19 • 5 years
|
|
Immune system disorders
Allergic reaction
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Investigations
Amylase increased
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
27.8%
5/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
General disorders
Chest pain
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
General disorders
Flu like symptoms
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
3/18 • 5 years
|
21.1%
4/19 • 5 years
|
|
Investigations
CPK increased
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Investigations
Creatinine increased
|
11.1%
2/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin- Other
|
11.1%
2/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
6/18 • 5 years
|
21.1%
4/19 • 5 years
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
2/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Endocrine disorders
Hyperparathyroidism
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Gastroenteritis
|
5.6%
1/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
General disorders
Fatigue
|
22.2%
4/18 • 5 years
|
26.3%
5/19 • 5 years
|
|
General disorders
Fever
|
11.1%
2/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Vascular disorders
Flushing
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal- Other
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • 5 years
|
26.3%
5/19 • 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
Heartburn
|
11.1%
2/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
2/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Investigations
Hyperbilirubinemia
|
5.6%
1/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.8%
5/18 • 5 years
|
21.1%
4/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
16.7%
3/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
2/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
2/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
1/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
1/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
38.9%
7/18 • 5 years
|
36.8%
7/19 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
3/18 • 5 years
|
15.8%
3/19 • 5 years
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
11.1%
2/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Investigations
Leukopenia
|
27.8%
5/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Investigations
Lymphopenia
|
11.1%
2/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
11.1%
2/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
Nail thinning
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • 5 years
|
15.8%
3/19 • 5 years
|
|
Investigations
Neutropenia
|
16.7%
3/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Eye disorders
Ocular-Other
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Nervous system disorders
Oculomotor nerve disorder
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Infections and infestations
Middle ear infection
|
5.6%
1/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • 5 years
|
21.1%
4/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
2/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Investigations
Thrombocytopenia
|
22.2%
4/18 • 5 years
|
15.8%
3/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary- Other
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
4/18 • 5 years
|
15.8%
3/19 • 5 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
16.7%
3/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
General disorders
Rigors/chills
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Ulceration in right nare
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Investigations
Vitamin D deficiency
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Investigations
Weight loss
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
5.6%
1/18 • 5 years
|
0.00%
0/19 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
3/18 • 5 years
|
10.5%
2/19 • 5 years
|
|
Reproductive system and breast disorders
Sexual-Other
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Small groundglass focus of airspace disease
|
0.00%
0/18 • 5 years
|
5.3%
1/19 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place