Trial Outcomes & Findings for Adjuvant Low Dose Aspirin in Colorectal Cancer (NCT NCT02647099)
NCT ID: NCT02647099
Last Updated: 2026-03-13
Results Overview
Number of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
626 participants
Primary outcome timeframe
3 years
Results posted on
2026-03-13
Participant Flow
First patient initial screening April 6, 2016. Last patient initial screening April 28, 2021. First patient randomized April 7, 2016. Last patient randomized July 19, 2021.
Participant milestones
| Measure |
Aspirin
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
One tablet placebo orally once daily for three years
|
|---|---|---|
|
Overall Study
STARTED
|
313
|
313
|
|
Overall Study
COMPLETED
|
311
|
312
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Aspirin
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
One tablet placebo orally once daily for three years
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Aspirin
n=313 Participants
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
n=313 Participants
One tablet placebo orally once daily for three years
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=313 Participants
|
0 Participants
n=313 Participants
|
0 Participants
n=626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
147 Participants
n=313 Participants
|
140 Participants
n=313 Participants
|
287 Participants
n=626 Participants
|
|
Age, Categorical
>=65 years
|
166 Participants
n=313 Participants
|
173 Participants
n=313 Participants
|
339 Participants
n=626 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=313 Participants
|
160 Participants
n=313 Participants
|
324 Participants
n=626 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=313 Participants
|
153 Participants
n=313 Participants
|
302 Participants
n=626 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
244 Participants
n=313 Participants
|
245 Participants
n=313 Participants
|
489 Participants
n=626 Participants
|
|
Region of Enrollment
Norway
|
32 Participants
n=313 Participants
|
37 Participants
n=313 Participants
|
69 Participants
n=626 Participants
|
|
Region of Enrollment
Denmark
|
19 Participants
n=313 Participants
|
14 Participants
n=313 Participants
|
33 Participants
n=626 Participants
|
|
Region of Enrollment
Finland
|
18 Participants
n=313 Participants
|
17 Participants
n=313 Participants
|
35 Participants
n=626 Participants
|
|
Tumour location
Right colon
|
137 Participants
n=313 Participants
|
142 Participants
n=313 Participants
|
279 Participants
n=626 Participants
|
|
Tumour location
Left colon
|
71 Participants
n=313 Participants
|
66 Participants
n=313 Participants
|
137 Participants
n=626 Participants
|
|
Tumour location
Colon (side not specified)
|
1 Participants
n=313 Participants
|
2 Participants
n=313 Participants
|
3 Participants
n=626 Participants
|
|
Tumour location
Rectum
|
104 Participants
n=313 Participants
|
103 Participants
n=313 Participants
|
207 Participants
n=626 Participants
|
|
Somatic alteration
PIK3CA exon 9/20 hotspot mutations
|
157 Participants
n=313 Participants
|
157 Participants
n=313 Participants
|
314 Participants
n=626 Participants
|
|
Somatic alteration
Other PI3K alterations
|
156 Participants
n=313 Participants
|
156 Participants
n=313 Participants
|
312 Participants
n=626 Participants
|
PRIMARY outcome
Timeframe: 3 yearsNumber of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
Outcome measures
| Measure |
Aspirin
n=313 Participants
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
n=313 Participants
One tablet placebo orally once daily for three years
|
|---|---|---|
|
Time To Recurrence (TTR)
|
24 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 3 yearsNumber of participants with local recurrence, distant metastases, a new malignant neoplasm, or death from any cause within 3 years from randomization
Outcome measures
| Measure |
Aspirin
n=313 Participants
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
n=313 Participants
One tablet placebo orally once daily for three years
|
|---|---|---|
|
Disease Free Survival (DFS)
|
38 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 5 yearsDeath from any cause within 5 years from randomization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year and 3 yearsPopulation: The safety population consists of participants who received at least one container of the study drug.
The frequency and severity of severe adverse events in the safety population
Outcome measures
| Measure |
Aspirin
n=309 Participants
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
n=311 Participants
One tablet placebo orally once daily for three years
|
|---|---|---|
|
Frequency and Severity of Adverse Events (AE)
Severe adverse events
|
52 Participants
|
36 Participants
|
|
Frequency and Severity of Adverse Events (AE)
Non-severe adverse events
|
134 Participants
|
110 Participants
|
Adverse Events
Aspirin
Serious events: 52 serious events
Other events: 134 other events
Deaths: 25 deaths
Placebo
Serious events: 36 serious events
Other events: 110 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Aspirin
n=309 participants at risk
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
n=311 participants at risk
One tablet placebo orally once daily for three years
|
|---|---|---|
|
Cardiac disorders
Cardiac infarction
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Stoma complication
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Blood and lymphatic system disorders
Cerebral aneurysm
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.64%
2/311 • Number of events 2 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Covid-19 infection
|
0.65%
2/309 • Number of events 2 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
General disorders
Death, unknown cause
|
0.65%
2/309 • Number of events 2 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
9/309 • Number of events 9 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
2.3%
7/311 • Number of events 7 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Vascular disorders
Embolism left cardiac ventricle
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Gastroenteritis
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Hernia
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Ileus
|
3.6%
11/309 • Number of events 11 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.64%
2/311 • Number of events 2 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Injury, poisoning and procedural complications
Injury
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.96%
3/311 • Number of events 3 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Vascular disorders
Ischemic stroke
|
0.65%
2/309 • Number of events 2 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Cardiac disorders
Pacemaker surgery
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Parastomal hernia
|
0.65%
2/309 • Number of events 3 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Perianal abscess
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Peritoneal abcess
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Reproductive system and breast disorders
Planned gynecological surgery
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Musculoskeletal and connective tissue disorders
Planned orthopaedic surgery
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Cardiac disorders
Cardiac arrest
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Immune system disorders
Allergic reaction
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Anastomotic leak
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Immune system disorders
Polyangiitis
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Post-surgical infection
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Presacral abcess
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Vascular disorders
Pulmonary embolism
|
1.3%
4/309 • Number of events 4 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.96%
3/311 • Number of events 3 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Pyelitis
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Rectal blowout
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Cardiac disorders
ST segment elevation
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Suspected cancer recurrence
|
0.00%
0/309 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Hepatobiliary disorders
Toxic hepatitis
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.00%
0/311 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Vascular disorders
Transient ischemic attack
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.32%
1/311 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/309 • Number of events 1 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
0.64%
2/311 • Number of events 2 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
Other adverse events
| Measure |
Aspirin
n=309 participants at risk
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
|
Placebo
n=311 participants at risk
One tablet placebo orally once daily for three years
|
|---|---|---|
|
Blood and lymphatic system disorders
Adverse event of the hematologic organ system
|
16.5%
51/309 • Number of events 77 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
10.6%
33/311 • Number of events 39 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Skin and subcutaneous tissue disorders
Adverse event of the skin
|
6.5%
20/309 • Number of events 22 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
5.8%
18/311 • Number of events 20 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Adverse event of the gastrointestinal organ system
|
16.8%
52/309 • Number of events 72 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
15.8%
49/311 • Number of events 65 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
5.8%
18/309 • Number of events 23 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
6.4%
20/311 • Number of events 24 • From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.
Non-serious adverse events were monitored without regard to the specific Adverse Event Term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place