Trial Outcomes & Findings for Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules (NCT NCT02169271)
NCT ID: NCT02169271
Last Updated: 2020-05-21
Results Overview
Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
Twelve-month treatment
Results posted on
2020-05-21
Participant Flow
A total of 619 ld-CT scans, belonging to the lung screening programs, showed potentially eligible nodules. A total of 109 subjects signed a written informed consent and underwent baseline visit while 98 have been randomized.
After enrollment, 11 participants were not randomized (baseline screening failures)
Participant milestones
| Measure |
Aspirin
1 tablet of aspirin 100 mg a day for one year
|
Placebo
1 tablet of placebo a day for one year
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Aspirin
1 tablet of aspirin 100 mg a day for one year
|
Placebo
1 tablet of placebo a day for one year
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules
Baseline characteristics by cohort
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 4.1 • n=99 Participants
|
64.6 years
STANDARD_DEVIATION 4.7 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
48 participants
n=99 Participants
|
49 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
Sum of longest diameters of baseline target nodules
|
8.5 millimeters
STANDARD_DEVIATION 4.3 • n=99 Participants
|
11 millimeters
STANDARD_DEVIATION 11.3 • n=107 Participants
|
9.8 millimeters
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Sum of diameters of baseline target nodules
|
6.8 millimeters
STANDARD_DEVIATION 2.8 • n=99 Participants
|
7.2 millimeters
STANDARD_DEVIATION 2.7 • n=107 Participants
|
7.0 millimeters
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
Baseline lesion volume
|
138 Millimeter^3
STANDARD_DEVIATION 139 • n=99 Participants
|
151 Millimeter^3
STANDARD_DEVIATION 151 • n=107 Participants
|
145 Millimeter^3
STANDARD_DEVIATION 145 • n=206 Participants
|
|
Baseline lesion density
|
-628 Hounsfield Unit
STANDARD_DEVIATION 76 • n=99 Participants
|
-663 Hounsfield Unit
STANDARD_DEVIATION 98 • n=107 Participants
|
-647 Hounsfield Unit
STANDARD_DEVIATION 90 • n=206 Participants
|
|
Circulating biomarkers and miRNA risk score
|
10.4 Score on a scale
STANDARD_DEVIATION 9.5 • n=99 Participants
|
10 Score on a scale
STANDARD_DEVIATION 10.6 • n=107 Participants
|
10.2 Score on a scale
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Circulating Thromboxane
|
60.4 ng/mL
STANDARD_DEVIATION 32.6 • n=99 Participants
|
61.1 ng/mL
STANDARD_DEVIATION 37.3 • n=107 Participants
|
60.8 ng/mL
STANDARD_DEVIATION 34.8 • n=206 Participants
|
|
Circulating Prostaglandin E metabolite (PGEM) normalized to uCr concentration
|
385 pg/mg creatinine
STANDARD_DEVIATION 218 • n=99 Participants
|
334 pg/mg creatinine
STANDARD_DEVIATION 213 • n=107 Participants
|
359 pg/mg creatinine
STANDARD_DEVIATION 216 • n=206 Participants
|
|
Circulating Leukotriene E4 normalized to uCr concentration
|
1701 pg/mg creatinine
STANDARD_DEVIATION 1670 • n=99 Participants
|
1226 pg/mg creatinine
STANDARD_DEVIATION 909 • n=107 Participants
|
1463 pg/mg creatinine
STANDARD_DEVIATION 1359 • n=206 Participants
|
|
Circulating High sensitive CRP
|
0.47 mg/dL
STANDARD_DEVIATION 1.01 • n=99 Participants
|
0.29 mg/dL
STANDARD_DEVIATION 0.52 • n=107 Participants
|
0.38 mg/dL
STANDARD_DEVIATION 0.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Twelve-month treatmentDifference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)
|
0.3 millimeter (mm)
Standard Deviation 2.54
|
-0.12 millimeter (mm)
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Baseline up to 1 yearDifference (12 month-baseline) in the sum of baseline target nodules diameters
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)
|
0.1 millimeter (mm)
Standard Deviation 2.4
|
-0.1 millimeter (mm)
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline to 1 yearDifference (12 month-baseline) in lesion volume
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Change in Lesion Volume
|
-4.5 millimiter^3 (mm3)
Standard Deviation 78
|
-4.8 millimiter^3 (mm3)
Standard Deviation 134
|
SECONDARY outcome
Timeframe: Baseline up to 1 yearDifference (12 month-baseline) in lesion density
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Change in Lesion Density
|
24 Hounsfield unit (HU)
Standard Deviation 65
|
28 Hounsfield unit (HU)
Standard Deviation 78
|
SECONDARY outcome
Timeframe: Baseline up to 1 yearDifference (12 month-baseline) in biomarker concentration
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Modulation of Thromboxane B2
|
-35.8 ng/mL
Standard Deviation 53.4
|
20.5 ng/mL
Standard Deviation 50.7
|
SECONDARY outcome
Timeframe: Baseline up to 1 yearDifference (12 month-baseline) in biomarker concentration
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)
|
-60.7 pg/mg creatinine
Standard Deviation 210
|
29.8 pg/mg creatinine
Standard Deviation 215
|
SECONDARY outcome
Timeframe: Baseline up to 1 yearDifference (12 month-baseline) in biomarker concentration
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Modulation of Leukotriene E4 (Normalized to Urinary Creatinine Concentration)
|
-235 pg/mg creatinine
Standard Deviation 1240
|
-9 pg/mg creatinine
Standard Deviation 592
|
SECONDARY outcome
Timeframe: Baseline up to 1 yearDifference (12 month-baseline) in biomarker concentration
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Modulation of High Sensitive CRP
|
-0.12 mg/dL
Standard Deviation 0.88
|
-0.08 mg/dL
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline up to 1 yearDifference (12 month-baseline) of the score on a scale (scale from -20 to +30 which measure the risk of lung cancer. Higher values indicate higher risk. A value\<0 is considered negative, a value ≥0 positive for lung cancer).
Outcome measures
| Measure |
Aspirin
n=49 Participants
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 Participants
1 tablet of placebo a day for one year
|
|---|---|---|
|
Modulation of miRNA Prediction Risk Score
|
0.14 Score on a scale
Standard Deviation 8.94
|
0.36 Score on a scale
Standard Deviation 7.36
|
Adverse Events
Aspirin
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin
n=49 participants at risk
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 participants at risk
1 tablet of placebo a day for one year
|
|---|---|---|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Infections and infestations
Balanitis
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Increased volume of target lesion
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
4.1%
2/49 • Number of events 3 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Surgical and medical procedures
Anal fissures
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Surgical and medical procedures
Penile implant
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
Other adverse events
| Measure |
Aspirin
n=49 participants at risk
1 tablet of aspirin 100 mg a day for one year
|
Placebo
n=49 participants at risk
1 tablet of placebo a day for one year
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/49 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Ear and labyrinth disorders
Vertigo
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Ear and labyrinth disorders
Other
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Eye disorders
Conjunctivitis
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Eye disorders
Vitreous hemorrage
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Eye disorders
Other
|
4.1%
2/49 • Number of events 4 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
4/49 • Number of events 5 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Oral hemorrage
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Periodontal disease
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
7/49 • Number of events 7 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrage
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Stomach pain
|
8.2%
4/49 • Number of events 5 • Baseline up to 13 months
|
6.1%
3/49 • Number of events 6 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Hemorroidal hemorrage
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 6 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 3 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/49 • Baseline up to 13 months
|
10.2%
5/49 • Number of events 5 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Hemorroids
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder, other
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
General disorders
Flu-like symptoms
|
10.2%
5/49 • Number of events 5 • Baseline up to 13 months
|
14.3%
7/49 • Number of events 8 • Baseline up to 13 months
|
|
General disorders
Localized edema
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
General disorders
Non-cardia chest pain
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
General disorders
Fever
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
General disorders
Malaise
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
|
Infections and infestations
Upper respiratory infection
|
6.1%
3/49 • Number of events 6 • Baseline up to 13 months
|
8.2%
4/49 • Number of events 4 • Baseline up to 13 months
|
|
Infections and infestations
Otitis externa
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Infections and infestations
Bronchial infection
|
20.4%
10/49 • Number of events 18 • Baseline up to 13 months
|
10.2%
5/49 • Number of events 10 • Baseline up to 13 months
|
|
Infections and infestations
Urinary tract infection
|
8.2%
4/49 • Number of events 8 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Infections and infestations
Tooth infection
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Infections and infestations
Penile Infection
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Infections and infestations
Laryingitis
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Infections and infestations
Nail infection
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Infections and infestations
Otitis media
|
0.00%
0/49 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Infections and infestations
Other
|
6.1%
3/49 • Number of events 3 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Injury, poisoning and procedural complications
Other
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Investigations
Cholesterol high
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Investigations
ALT increased
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Investigations
AST increased
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Investigations
Bilirubin increased
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Investigations
Other
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
3/49 • Number of events 7 • Baseline up to 13 months
|
14.3%
7/49 • Number of events 13 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
4/49 • Number of events 4 • Baseline up to 13 months
|
12.2%
6/49 • Number of events 13 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.1%
2/49 • Number of events 3 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/49 • Baseline up to 13 months
|
8.2%
4/49 • Number of events 4 • Baseline up to 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Nervous system disorders
Headache
|
14.3%
7/49 • Number of events 10 • Baseline up to 13 months
|
8.2%
4/49 • Number of events 12 • Baseline up to 13 months
|
|
Nervous system disorders
Paresthesia
|
4.1%
2/49 • Number of events 5 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
|
Nervous system disorders
Other
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/49 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Psychiatric disorders
Other
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Renal and urinary disorders
Hematuria
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
8.2%
4/49 • Number of events 6 • Baseline up to 13 months
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Renal and urinary disorders
Renal colic
|
4.1%
2/49 • Number of events 3 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Reproductive system and breast disorders
Vaginal hemorrage
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Reproductive system and breast disorders
Prostatic pain
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Reproductive system and breast disorders
Vagynal dryness
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 2 • Baseline up to 13 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Reproductive system and breast disorders
Other
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.2%
5/49 • Number of events 7 • Baseline up to 13 months
|
12.2%
6/49 • Number of events 9 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxix
|
4.1%
2/49 • Number of events 5 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
6/49 • Number of events 10 • Baseline up to 13 months
|
14.3%
7/49 • Number of events 8 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/49 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore theroat
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
|
Skin and subcutaneous tissue disorders
Other
|
4.1%
2/49 • Number of events 2 • Baseline up to 13 months
|
4.1%
2/49 • Number of events 3 • Baseline up to 13 months
|
|
Surgical and medical procedures
Other
|
8.2%
4/49 • Number of events 5 • Baseline up to 13 months
|
8.2%
4/49 • Number of events 4 • Baseline up to 13 months
|
|
Vascular disorders
Hematoma
|
4.1%
2/49 • Number of events 3 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Vascular disorders
Phlebitis
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
0.00%
0/49 • Baseline up to 13 months
|
|
Vascular disorders
Hypertension
|
8.2%
4/49 • Number of events 4 • Baseline up to 13 months
|
6.1%
3/49 • Number of events 18 • Baseline up to 13 months
|
|
Vascular disorders
Other
|
0.00%
0/49 • Baseline up to 13 months
|
2.0%
1/49 • Number of events 1 • Baseline up to 13 months
|
Additional Information
Dr. Therese Bevers / Clinical Cancer Prevention Department
UT MD Anderson Cancer Center
Phone: 713-745-8048
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60