Trial Outcomes & Findings for Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma (NCT NCT02965703)
NCT ID: NCT02965703
Last Updated: 2025-08-07
Results Overview
Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: BAX density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Baseline to end of intervention up to 12 weeks
Results posted on
2025-08-07
Participant Flow
81 participants were randomized. 70 out of the 81 started study agent.
Participant milestones
| Measure |
Arm I (Aspirin)
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
33
|
8
|
|
Overall Study
COMPLETED
|
19
|
28
|
6
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Aspirin)
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
Baseline Characteristics
Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma
Baseline characteristics by cohort
| Measure |
Arm I (Aspirin)
n=36 Participants
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
n=36 Participants
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
n=9 Participants
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 6 • n=7 Participants
|
57 years
STANDARD_DEVIATION 6 • n=5 Participants
|
60 years
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
9 participants
n=5 Participants
|
81 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of intervention up to 12 weeksPopulation: Participants with pre and post intervention samples available.
Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: BAX density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants
Outcome measures
| Measure |
Arm I (Aspirin)
n=14 Participants
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
n=23 Participants
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
n=4 Participants
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index)
|
-0.11 ratio
Interval -0.26 to 1.26
|
0.00 ratio
Interval -0.42 to 0.92
|
-0.23 ratio
Interval -0.32 to -0.03
|
SECONDARY outcome
Timeframe: Baseline to end of intervention up to 12 weeksPopulation: Participants with pre and post intervention samples available.
Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: TUNEL density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants.
Outcome measures
| Measure |
Arm I (Aspirin)
n=14 Participants
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
n=23 Participants
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
n=4 Participants
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Ratio of Cell Proliferation (Ki-67)/Apoptosis (TdT-mediated dUTP Nick End Labeling [TUNEL]) in Rectal Biopsies
|
-1.27 ratio
Interval -1.66 to 0.99
|
0.63 ratio
Interval -0.2 to 1.78
|
-0.70 ratio
Interval -2.32 to 0.71
|
SECONDARY outcome
Timeframe: Baseline to end of intervention up to 12 weeksPopulation: Participants with pre and post intervention samples available.
Change in the ratio of proliferation to necroptosis biomarkers (Ki67 density index: pMLKLdensity index, measured continuously after IHC staining) in colorectal mucosa of compliant participants
Outcome measures
| Measure |
Arm I (Aspirin)
n=14 Participants
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
n=23 Participants
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
n=4 Participants
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Ratio of Cell Proliferation (Ki-67)/Necroptosis (MLKL) in Rectal Biopsies
|
0.58 ratio
Interval -0.84 to 0.79
|
-0.02 ratio
Interval -0.53 to 0.39
|
-0.32 ratio
Interval -1.39 to 0.77
|
SECONDARY outcome
Timeframe: Baseline to end of intervention up to 12 weeks.Population: Participants with pre and post intervention samples available.
The number of participants who started intervention and had a positive fecal occult blood test result
Outcome measures
| Measure |
Arm I (Aspirin)
n=20 Participants
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
n=30 Participants
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
n=7 Participants
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Fecal Occult Blood Test (Measures of Adverse Events) as Measured by Stool Samples
|
1 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Arm I (Aspirin)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm II (Aspirin, Placebo)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm III (Placebo)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Aspirin)
n=29 participants at risk
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
n=33 participants at risk
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
n=8 participants at risk
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
3.0%
1/33 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
Other adverse events
| Measure |
Arm I (Aspirin)
n=29 participants at risk
Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm II (Aspirin, Placebo)
n=33 participants at risk
Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Aspirin: Given PO
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
Arm III (Placebo)
n=8 participants at risk
Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.
Biospecimen Collection: Undergo collection of blood, urine, stool, and rectal swab samples
Placebo Administration: Given PO
Questionnaire Administration: Ancillary studies
Rectal Biopsy: Undergo rectal biopsy
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.9%
2/29 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
6.1%
2/33 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.9%
2/29 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Infections and infestations
Upper respiratory infection
|
6.9%
2/29 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.1%
4/33 • Number of events 4 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
6.1%
2/33 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
6.1%
2/33 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
6.1%
2/33 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
6.1%
2/33 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/8 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
6.9%
2/29 • Number of events 2 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/29 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
0.00%
0/33 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
12.5%
1/8 • Number of events 1 • AEs collected from the time of first dose of aspirin or placebo, through 40 days post-intervention.
All participants will be evaluable for toxicity from the time of their first dose of aspirin or placebo
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60