Trial Outcomes & Findings for Vitamin D/Calcium Polyp Prevention Study (NCT NCT00153816)
NCT ID: NCT00153816
Last Updated: 2017-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
2813 participants
Primary outcome timeframe
1 to 10 years
Results posted on
2017-03-15
Participant Flow
Subjects were enrolled between July 2004 and July 2008 at 11 academic medical centers and associated gastroenterology practices in the U.S.
19,083 subjects were screened and 2,813 were enrolled into a run-in period of 56-84 days. 554 subjects were not randomized: 174 were ineligible due to out of range baseline lab values, 66 were ineligible for other reasons, 211 had \<80% tablet adherence, and 103 refused to participate.
Participant milestones
| Measure |
Two Arm Vitamin D
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Placebo
subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day
|
Full Factorial Calcium
subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Full Factorial Vitamin D
Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Calcium Plus Vitamin D
Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Two Arm Placebo
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
289
|
415
|
419
|
420
|
421
|
295
|
|
Overall Study
COMPLETED
|
262
|
383
|
387
|
388
|
390
|
278
|
|
Overall Study
NOT COMPLETED
|
27
|
32
|
32
|
32
|
31
|
17
|
Reasons for withdrawal
| Measure |
Two Arm Vitamin D
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Placebo
subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day
|
Full Factorial Calcium
subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Full Factorial Vitamin D
Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Calcium Plus Vitamin D
Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Two Arm Placebo
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
6
|
5
|
4
|
6
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
8
|
5
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
9
|
9
|
4
|
1
|
|
Overall Study
Follow-up exam not done
|
9
|
8
|
7
|
11
|
10
|
8
|
|
Overall Study
Follow-up exam done, histology missing
|
2
|
2
|
3
|
3
|
3
|
1
|
Baseline Characteristics
Vitamin D/Calcium Polyp Prevention Study
Baseline characteristics by cohort
| Measure |
Full Factorial Placebo
n=415 Participants
subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day
|
Full Factorial Calcium
n=419 Participants
subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Full Factorial Vitamin D
n=420 Participants
Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Calcium Plus Vitamin D
n=421 Participants
Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Two Arm Placebo
n=295 Participants
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Two Arm Vitamin D
n=289 Participants
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Total
n=2259 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
56.7 years
STANDARD_DEVIATION 6.0 • n=21 Participants
|
57.0 years
STANDARD_DEVIATION 6.6 • n=10 Participants
|
58.1 years
STANDARD_DEVIATION 6.8 • n=115 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
295 Participants
n=21 Participants
|
289 Participants
n=10 Participants
|
836 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
355 Participants
n=5 Participants
|
356 Participants
n=7 Participants
|
358 Participants
n=5 Participants
|
354 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1423 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
146 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
395 Participants
n=5 Participants
|
395 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
394 Participants
n=4 Participants
|
267 Participants
n=21 Participants
|
263 Participants
n=10 Participants
|
2110 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
51 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
184 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
357 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
350 Participants
n=4 Participants
|
238 Participants
n=21 Participants
|
237 Participants
n=10 Participants
|
1900 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
99 Participants
n=115 Participants
|
|
Region of Enrollment
Puerto Rico
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
7 participants
n=4 Participants
|
5 participants
n=21 Participants
|
4 participants
n=10 Participants
|
37 participants
n=115 Participants
|
|
Region of Enrollment
United States
|
408 participants
n=5 Participants
|
412 participants
n=7 Participants
|
413 participants
n=5 Participants
|
414 participants
n=4 Participants
|
290 participants
n=21 Participants
|
285 participants
n=10 Participants
|
2222 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 1 to 10 yearsPopulation: Subjects are included if they had a follow-up exam at least one year after randomization and had sufficient histology available to ascertain the endpoint.
Outcome measures
| Measure |
Full Factorial Placebo
n=380 Participants
subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day
|
Full Factorial Calcium
n=381 Participants
subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Full Factorial Vitamin D
n=381 Participants
Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Calcium Plus Vitamin D
n=381 Participants
Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Two Arm Placebo
n=274 Participants
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Two Arm Vitamin D
n=262 Participants
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
|---|---|---|---|---|---|---|
|
Colorectal Adenomas
|
48.2 percentage of subjects
Interval 43.0 to 53.3
|
44.9 percentage of subjects
Interval 39.8 to 50.0
|
47.0 percentage of subjects
Interval 41.9 to 52.1
|
45.7 percentage of subjects
Interval 40.6 to 50.8
|
32.1 percentage of subjects
Interval 26.6 to 38.0
|
32.4 percentage of subjects
Interval 26.8 to 38.5
|
SECONDARY outcome
Timeframe: 1 to 10 yearsPopulation: Subjects are included if they had a follow-up exam at least one year after randomization and sufficient histology available to ascertain the endpoint.
Includes: adenomas \>=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer.
Outcome measures
| Measure |
Full Factorial Placebo
n=380 Participants
subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day
|
Full Factorial Calcium
n=386 Participants
subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Full Factorial Vitamin D
n=384 Participants
Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Calcium Plus Vitamin D
n=387 Participants
Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Two Arm Placebo
n=276 Participants
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Two Arm Vitamin D
n=261 Participants
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
|---|---|---|---|---|---|---|
|
Advanced Colorectal Lesions
|
9.2 percentage of subjects
Interval 6.5 to 12.6
|
11.4 percentage of subjects
Interval 8.4 to 15.0
|
10.9 percentage of subjects
Interval 8.0 to 14.5
|
9.6 percentage of subjects
Interval 6.8 to 12.9
|
6.9 percentage of subjects
Interval 4.2 to 10.5
|
7.3 percentage of subjects
Interval 4.4 to 11.1
|
Adverse Events
Full Factorial Placebo
Serious events: 84 serious events
Other events: 46 other events
Deaths: 0 deaths
Full Factorial Calcium
Serious events: 94 serious events
Other events: 45 other events
Deaths: 0 deaths
Full Factorial Vitamin D
Serious events: 97 serious events
Other events: 47 other events
Deaths: 0 deaths
Full Factorial Calcium Plus Vitamin D
Serious events: 80 serious events
Other events: 61 other events
Deaths: 0 deaths
Two Arm Placebo
Serious events: 64 serious events
Other events: 53 other events
Deaths: 0 deaths
Two Arm Vitamin D
Serious events: 63 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Full Factorial Placebo
n=415 participants at risk
subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day
|
Full Factorial Calcium
n=419 participants at risk
subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Full Factorial Vitamin D
n=420 participants at risk
Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Calcium Plus Vitamin D
n=421 participants at risk
Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Two Arm Placebo
n=295 participants at risk
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Two Arm Vitamin D
n=289 participants at risk
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Blood and lymphatic system disorders
Myelodysplastic syndrome
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Cardiac disorders
Cardiac arrhythmia
|
0.96%
4/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.72%
3/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.95%
4/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.71%
3/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Cardiac disorders
Cardiac ischemia/myocardial infarction
|
0.96%
4/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
6/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Cardiac disorders
Congestive heart failure
|
0.72%
3/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Cardiac disorders
Valvular heart disease
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Ear and labyrinth disorders
Cochlear implant
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Endocrine disorders
Thyroid hyperplasia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.72%
3/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Colostomy take-down
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.68%
2/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Esophagitis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Hiatal hernia
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Ischemic colitis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Ulcer
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Alcohol intoxication
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Altered mental status
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Altitude sickness
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Chest pain
|
1.7%
7/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.9%
8/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.9%
8/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.7%
7/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
2.0%
6/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
4/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Deviated septum
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Epistaxis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Febrile Illness
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Groin hematoma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Multiple illnesses
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Septic shock
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Sleep apnea
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Syncope/near syncope
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.69%
2/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Toxic shock syndrome
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
Traumatic injury
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
General disorders
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Hepatobiliary disorders
Ascites
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.72%
3/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.95%
4/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.69%
2/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Hepatobiliary disorders
Hepatitis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Immune system disorders
Allergic reaction
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Abscess
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.68%
2/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Bronchitis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Cellulitis
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Death
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Febrile Illness
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Glottitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Infected prosthesis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Pneumonia
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.69%
2/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Respiratory failure
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Sepsis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Upper respiratory infection
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Urinary tract infection
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Infections and infestations
Wound infection
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Injury, poisoning and procedural complications
Postoperative hematoma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Injury, poisoning and procedural complications
Sigmoid perforation
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Injury, poisoning and procedural complications
Unintentional overdose
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Metabolism and nutrition disorders
Electrolyte disturbance
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.68%
2/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Flat feet
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.4%
6/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.2%
5/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.7%
5/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Gout/rheumatoid arthritis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Joint replacement
|
1.2%
5/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
2.6%
11/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
5.0%
21/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.1%
13/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.4%
10/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.8%
11/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Nerve entrapment
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Traumatic injury
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Ventral hernia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Back pain/degenerative spinal disorders
|
1.2%
5/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.72%
3/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.95%
4/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
2.1%
9/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign parotid tumor
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary cancer
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer/ductal carcinoma in situ
|
1.7%
1/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
4.8%
3/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.68%
2/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.69%
2/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system cancer
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.69%
2/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer/hyperplasia
|
3.3%
2/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.5%
1/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.68%
2/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Espohageal cancer
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck neoplasia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney cancer
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma/leukemia
|
0.72%
3/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.72%
3/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.72%
3/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloma
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.7%
1/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.69%
2/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal mesothelioma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate and bladder cancer
|
0.00%
0/355 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.28%
1/356 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/358 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/354 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
—
0/0 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
—
0/0 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
3.4%
12/355 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.4%
12/356 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.6%
13/358 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.7%
6/354 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
—
0/0 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
—
0/0 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serous ovarian tumor of low malignant potential
|
0.00%
0/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.6%
1/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin basal cell carcinoma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma type AB
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Central nervous system cerebrovascular ischemia
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Cerebral spinal fluid leak
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Hygroma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Migraine syndrome
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Multiple sclerosis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Seizure
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.68%
2/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Traumatic injury
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Nervous system disorders
Vestibular neuritis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Psychiatric disorders
Bipolar affective disorder
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Psychiatric disorders
Depression
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Psychiatric disorders
Steroid psychosis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Renal and urinary disorders
Cystitis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Renal and urinary disorders
Cystocele/rectocele
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.69%
2/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Renal and urinary disorders
Urolithiasis
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.72%
3/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.85%
3/355 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
5/356 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.1%
4/358 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.28%
1/354 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
—
0/0 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
—
0/0 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Breast surgery
|
0.00%
0/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Corpus luteum cyst
|
0.00%
0/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Fibroids
|
3.3%
2/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Pubovaginal sling
|
0.00%
0/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.5%
1/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.00%
0/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.6%
1/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/60 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/63 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.6%
1/62 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/67 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Respiratory, thoracic and mediastinal disorders
Traumatic injury
|
0.48%
2/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Skin and subcutaneous tissue disorders
Cosmetic surgery
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Cerebrovascular ischemia
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.71%
3/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.71%
3/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.0%
3/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
4/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Hypotension
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Revascularization
|
0.72%
3/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.7%
7/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.71%
3/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
6/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
4/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Subdural hematoma
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Sudden death
|
0.00%
0/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Traumatic injury
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.00%
0/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Vascular disorders
Venous thromboembolism
|
0.24%
1/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.48%
2/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
6/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.24%
1/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.34%
1/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
0.35%
1/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
Other adverse events
| Measure |
Full Factorial Placebo
n=415 participants at risk
subjects in 2X2 factorial design; randomized to daily placebo
placebo: placebo; two tablets per day
|
Full Factorial Calcium
n=419 participants at risk
subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Full Factorial Vitamin D
n=420 participants at risk
Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Full Factorial Calcium Plus Vitamin D
n=421 participants at risk
Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
Two Arm Placebo
n=295 participants at risk
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
|
Two Arm Vitamin D
n=289 participants at risk
Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3
Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.6%
15/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
2.9%
12/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.6%
15/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
5.0%
21/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
7.5%
22/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
2.4%
7/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-melanoma skin cancer
|
4.8%
20/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
6.2%
26/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
5.2%
22/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
6.7%
28/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.7%
11/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.8%
11/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.2%
5/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.9%
8/419 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.4%
6/420 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
1.7%
7/421 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
5.8%
17/295 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
5.5%
16/289 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
|
Renal and urinary disorders
Hypercreatinemia
|
5.2%
21/407 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
7.0%
29/412 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
4.6%
19/415 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
7.0%
29/413 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
5.8%
17/294 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
3.1%
9/287 • Events are included if they occur between randomization and 30 days after the subject exits the treatment phase of the trial, roughly 3 or 5 years after study entry, depending on when their next surveillance colonoscopy is expected.
Every 6 months, subjects were asked to report all hospitalizations and contacts with medical services. All events have been confirmed via medical record review by a study physician.
|
Additional Information
Leila A. Mott, Statistical Analyst
Geisel School of Medicine at Dartmouth
Phone: 603-650-3447
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place