Trial Outcomes & Findings for Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients (NCT NCT00151476)
NCT ID: NCT00151476
Last Updated: 2024-09-04
Results Overview
Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
Recruitment status
TERMINATED
Target enrollment
68 participants
Primary outcome timeframe
Up to 8 years prior to baseline
Results posted on
2024-09-04
Participant Flow
Study prematurely discontinued in May 2008 prior to reaching planned enrollment target; Last subject last visit November 2008.
Familial Adenomatous Polyposis (FAP) identified subjects=celecoxib-treated and matched control subjects eligible for inclusion in study identified from 4 registry sites; FAP analyzed=celecoxib-treated and matched control subjects eligible for matching and analysis in study. 1 subject excluded from analysis; took celecoxib without a prescription.
Participant milestones
| Measure |
Matched Control
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|
|
FAP Identified Subjects
STARTED
|
13
|
55
|
|
FAP Identified Subjects
COMPLETED
|
13
|
54
|
|
FAP Identified Subjects
NOT COMPLETED
|
0
|
1
|
|
FAP Analyzed Subjects
STARTED
|
13
|
54
|
|
FAP Analyzed Subjects
COMPLETED
|
13
|
51
|
|
FAP Analyzed Subjects
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Matched Control
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|
|
FAP Identified Subjects
Protocol Violation
|
0
|
1
|
|
FAP Analyzed Subjects
Lost to Follow-up
|
0
|
2
|
|
FAP Analyzed Subjects
Other study participation
|
0
|
1
|
Baseline Characteristics
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients
Baseline characteristics by cohort
| Measure |
Matched Celecoxib Treated
n=13 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=13 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=41 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
45 to 54 years
|
1 participants
11.24 • n=5 Participants
|
1 participants
9.00 • n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Age, Customized
<25 years
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Age, Customized
25 to 34 years
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Age, Customized
35 to 44 years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Age, Customized
55 to 64 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Age, Customized
>64 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Age, Customized
Age not available (no surgery)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 8 years prior to baselinePopulation: All eligible subjects with IRA performed prior to start of study follow-up; first excisional polypectomy of rectal polyp post IRA. Polyp size unavailable for many subjects; not considered in analysis.
Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
Outcome measures
| Measure |
Matched Celecoxib Treated
n=4 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=2 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=26 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=30 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
|
86.4 months
Standard Deviation 143.78
|
4.0 months
Standard Deviation 3.25
|
78.4 months
Standard Deviation 102.01
|
79.5 months
Standard Deviation 105.44
|
PRIMARY outcome
Timeframe: Baseline, Up to 60 months post-baselinePopulation: All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy of rectal polyp post IRA prior to start of study follow-up). No control group subjects (n=3) had a post-IRA polypectomy (no data).
Time(months): \[date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1\] divided by 30.44.
Outcome measures
| Measure |
Matched Celecoxib Treated
n=1 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=5 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=6 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA
|
19.8 months
Full Range 17.14 • Interval 19.8 to 19.8
|
—
|
32.1 months
Interval 0.0 to 44.1
|
25.9 months
Interval 0.0 to 44.1
|
PRIMARY outcome
Timeframe: Up to 15 years prior to baselinePopulation: All eligible subjects with IPAA performed prior to start of study follow-up included and with first excisional polypectomy of a rectal polyp post IPAA. No control group subjects (n=7) had a post-IPAA polypectomy (no data).
Time (months): \[date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1\] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient's most recent FAP-related surgery date=index date for Matched Control.
Outcome measures
| Measure |
Matched Celecoxib Treated
n=3 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=3 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
|
152.7 months
Standard Deviation 42.10
|
—
|
—
|
152.7 months
Standard Deviation 42.10
|
PRIMARY outcome
Timeframe: Baseline, Up to 60 months post-baselinePopulation: All eligible subjects with IPAA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy post IPAA prior to start of study follow-up). No control group subjects (n=7) had a post-IPAA polypectomy (no data).
Time (months): \[date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1\] divided by 30.44.
Outcome measures
| Measure |
Matched Celecoxib Treated
n=3 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=3 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA
|
20.3 months
Standard Deviation 15.72
|
—
|
—
|
20.3 months
Standard Deviation 15.72
|
SECONDARY outcome
Timeframe: Up to 15 years prior to baselinePopulation: All eligible subjects; first excisional or ablational event for rectal adenomas that does not qualify for primary efficacy endpoint; after most recent FAP-related surgical event prior to start of study follow-up or onset of FAP phenotype for subjects with no prior FAP-related surgery.
Time (months): \[date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1\] divided by 30.44.
Outcome measures
| Measure |
Matched Celecoxib Treated
n=8 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=8 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=33 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=41 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)
|
25.7 months
Standard Deviation 18.71
|
47.7 months
Standard Deviation 42.32
|
89.9 months
Standard Deviation 89.34
|
77.4 months
Standard Deviation 84.32
|
SECONDARY outcome
Timeframe: Baseline, Up to 60 months post-baselinePopulation: All eligible subjects included, except left censored subjects (had any excisional or ablational event for rectal, colonic, pouch, or duodenal adenomas between date of most recent FAP-related surgical event performed prior to the start of study follow-up, or onset of FAP phenotype \[with no prior FAP-related surgery\], and start of study follow-up).
Time (months): \[date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1\] divided by 30.44.
Outcome measures
| Measure |
Matched Celecoxib Treated
n=2 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=3 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=3 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=5 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas
|
0.0 months
Standard Deviation 0.0
|
41.7 months
Standard Deviation 21.73
|
21.4 months
Standard Deviation 22.39
|
12.9 months
Standard Deviation 19.71
|
SECONDARY outcome
Timeframe: Up to 15 years prior to baselinePopulation: All eligible subjects; first FAP-related adverse event (FAP-related cancers, desmoid tumors requiring procedural intervention, hospitalizations, procedural interventions, or death related to FAP) after subject's most recent FAP-related surgical event performed prior to start of study follow-up, onset of FAP phenotype (no prior FAP-related surgery).
Time (months): \[date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1\] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
Outcome measures
| Measure |
Matched Celecoxib Treated
n=5 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=6 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=30 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=35 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event
|
3.0 months
Full Range 123.17 • Interval 0.2 to 167.0
|
3.4 months
Full Range 48.34 • Interval 2.5 to 123.8
|
61.4 months
Interval 1.1 to 362.9
|
56.3 months
Interval 0.2 to 362.9
|
SECONDARY outcome
Timeframe: Baseline, Up to 60 months post-baselinePopulation: All eligible subjects included, except left-censored subjects (had any FAP-related adverse event between the date of most recent FAP-related surgical event performed prior to start of study follow-up, or onset of FAP phenotype (no prior FAP-related surgery), and start of study follow-up.
Time (months): \[date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1\] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).
Outcome measures
| Measure |
Matched Celecoxib Treated
n=1 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=1 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=7 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=8 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Start of Study Follow-up to Time of First FAP-related Adverse Event
|
37.9 months
Interval 37.9 to 37.9
|
75.7 months
Interval 75.7 to 75.7
|
9.7 months
Interval 0.8 to 37.7
|
14.3 months
Interval 0.8 to 37.9
|
SECONDARY outcome
Timeframe: Up to 15 years prior to baselinePopulation: All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data).
Time (months): \[date of IPAA minus date of prior IRA plus 1\] divided by 30.44.
Outcome measures
| Measure |
Matched Celecoxib Treated
n=1 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=9 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=10 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Post IRA to Time of Conversion From IRA to IPAA
|
301.6 months
Interval 301.6 to 301.6
|
—
|
129.7 months
Interval 8.0 to 362.9
|
175.8 months
Interval 8.0 to 362.9
|
SECONDARY outcome
Timeframe: Baseline, Up to 60 months post-baselinePopulation: All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had IPAA prior to start of study follow-up); data censored (n=5) for control group subjects (no data).
Time (months): \[date of IPAA minus date of start of study follow-up plus 1\] divided by 30.44.
Outcome measures
| Measure |
Matched Celecoxib Treated
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=2 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=2 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA
|
—
|
—
|
4.8 months
Interval 0.0 to 9.7
|
4.8 months
Interval 0.0 to 9.7
|
SECONDARY outcome
Timeframe: Baseline, 6 to 14 months post-baseline, End of study (EOS)Population: All subjects; Spigelman Stage not completed as staging data largely missing.
Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 to 14 months post-baseline, EOSPopulation: All subjects; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.
Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: \<100 polyps, mild: between 100 to 1000 polyps, severe: \>1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).
Outcome measures
| Measure |
Matched Celecoxib Treated
n=13 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=13 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=41 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=54 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Baseline attenuated
|
9 particpants
|
4 particpants
|
18 particpants
|
27 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Baseline mild
|
2 particpants
|
2 particpants
|
2 particpants
|
4 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Baseline severe
|
0 particpants
|
0 particpants
|
0 particpants
|
0 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Baseline unknown
|
1 particpants
|
0 particpants
|
12 particpants
|
13 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Baseline no polyps
|
1 particpants
|
6 particpants
|
4 particpants
|
5 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Baseline not assessed
|
0 particpants
|
1 particpants
|
5 particpants
|
5 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Post-baseline attenuated
|
6 particpants
|
3 particpants
|
10 particpants
|
16 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Post-baseline mild
|
0 particpants
|
0 particpants
|
1 particpants
|
1 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Post-baseline severe
|
0 particpants
|
0 particpants
|
0 particpants
|
0 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Post-baseline unknown
|
0 particpants
|
0 particpants
|
0 particpants
|
0 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Post-baseline no polyps
|
4 particpants
|
5 particpants
|
1 particpants
|
5 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
Post-baseline not assessed
|
3 particpants
|
5 particpants
|
29 particpants
|
32 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
EOS attenuated
|
8 particpants
|
2 particpants
|
12 particpants
|
20 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
EOS mild
|
0 particpants
|
0 particpants
|
0 particpants
|
0 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
EOS severe
|
0 particpants
|
0 particpants
|
0 particpants
|
0 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
EOS unknown
|
3 particpants
|
0 particpants
|
1 particpants
|
4 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
EOS no polyps
|
2 particpants
|
6 particpants
|
2 particpants
|
4 particpants
|
|
Rectal or Pouch Adenoma Burden Based on Polyp Counts
EOS not assessed
|
0 particpants
|
5 particpants
|
26 particpants
|
26 particpants
|
POST_HOC outcome
Timeframe: Baseline, 6 to 14 months post-baseline, End of study (EOS)Population: All subjects; Spigelman Stage not completed as staging data largely missing; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.
Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: \<100 polyps, mild: between 100 to 1000 polyps, severe: \>1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Post-hoc analysis of duodenal polyp burden in terms of severity categories and based on polyp numbers; Spigelman Stage not completed as staging data largely missing (see: Duodenal adenoma burden as measured by Spigelman Stage)
Outcome measures
| Measure |
Matched Celecoxib Treated
n=13 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Matched Control
n=13 Participants
Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
Not Matched Celecoxib Treated
n=41 Participants
Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
All Celecoxib Treated
n=54 Participants
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|---|---|---|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Baseline attenuated
|
5 participants
|
1 participants
|
18 participants
|
23 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Baseline mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Baseline severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Baseline unknown
|
3 participants
|
2 participants
|
10 participants
|
13 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Baseline no polyps
|
1 participants
|
5 participants
|
5 participants
|
6 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Baseline not assessed
|
4 participants
|
5 participants
|
8 participants
|
12 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Post-baseline attenuated
|
1 participants
|
3 participants
|
12 participants
|
13 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Post-baseline mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Post-baseline severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Post-baseline unknown
|
3 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Post-baseline no polyps
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
Post-baseline not assessed
|
8 participants
|
7 participants
|
29 participants
|
37 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
EOS attenuated
|
2 participants
|
2 participants
|
17 participants
|
19 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
EOS mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
EOS severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
EOS unknown
|
1 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
EOS no polyps
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Duodenal Adenoma Burden as Measured by Polyp Counts
EOS not assessed
|
9 participants
|
10 participants
|
20 participants
|
29 participants
|
Adverse Events
All Celecoxib Treated
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Celecoxib Treated
n=54 participants at risk
All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/54 • Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.
All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/54 • Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.
All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.
|
|
Gastrointestinal disorders
Duodenal perforation
|
1.9%
1/54 • Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.
All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
1.9%
1/54 • Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.
All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54 • Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.
All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/54 • Up to 15 years prior to baseline; up to 5 years post-baseline. No safety information actively searched for among celecoxib-treated subjects for retrospectively collected data (medical records); if serious adverse event (SAE) found, it was reported as SAE.
All SAEs, expected and unexpected, occurring while subject was receiving celecoxib during his/her prospective (on-study) participation in the study, regardless of the apparent relationship to the drug, were collected and reported to the sponsor. Not applicable to Matched Control subjects n=13; SAEs not collected if no celecoxib treatment received.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER