Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A3191167 |
Not provided
Not provided
Not provided
See Detailed Description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib.
Both retrospective and prospective data will be utilized. No sampling methods apply.
The study prematurely discontinued on April 11, 2008 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib - Routine Medical Care | 800 mg total daily dosing |
| |
| Control Group - Routine Medical Care | Observation of subjects treated with routine medical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 800 mg total daily dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | 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. | Up to 8 years prior to baseline |
| Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | 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. | Baseline, Up to 60 months post-baseline |
| Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | 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. | Up to 15 years prior to baseline |
| Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
Not provided
Inclusion Criteria:
Celecoxib Treated Patients:
Historical/Concurrent Control Patients:
Exclusion Criteria:
Celecoxib Treated Patients:
Historical/Concurrent Control Patients:
Not provided
Not provided
Not provided
Patients with FAP
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cleveland | Ohio | 44195 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Study prematurely discontinued in May 2008 prior to reaching planned enrollment target; Last subject last visit November 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FAP Identified Subjects |
|
| ||||||||||||||||||
| FAP Analyzed Subjects |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age range groups at most recent FAP-related surgery (years). Prior to start of study follow-up = prior to baseline. Start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and index date for control subjects = baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | 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. | 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. | Posted | Mean | Standard Deviation | months | Up to 8 years prior to baseline |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v11.1 | Systematic Assessment |
Not provided
Study prematurely discontinued May 2008 prior to reaching enrollment target; due to limited number of matched pairs, results do not provide sufficient data to evaluate effectiveness of celecoxib. Last subject last visit was November 2008.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| Routine Medical Care | Other |
|
| Baseline, Up to 60 months post-baseline |
| Up to 15 years prior to baseline |
| Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas | 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. | Baseline, Up to 60 months post-baseline |
| Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event | 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). | Up to 15 years prior to baseline |
| Time From Start of Study Follow-up to Time of First FAP-related Adverse Event | 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). | Baseline, Up to 60 months post-baseline |
| Time From Post IRA to Time of Conversion From IRA to IPAA | Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44. | Up to 15 years prior to baseline |
| Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA | Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44. | Baseline, Up to 60 months post-baseline |
| Duodenal Adenoma Burden as Measured by Spigelman Stage | 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. | Baseline, 6 to 14 months post-baseline, End of study (EOS) |
| Rectal or Pouch Adenoma Burden Based on Polyp Counts | 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). | Baseline, 6 to 14 months post-baseline, EOS |
| Toronto |
| Ontario |
| M5G1X5 |
| Canada |
| Pfizer Investigational Site | Hvidovre | Copenhagen | DK-2650 | Denmark |
| Pfizer Investigational Site | Barcelona | 08036 | Spain |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| Primary | Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA | 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. | 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). | Posted | Median | Full Range | months | Baseline, Up to 60 months post-baseline |
|
|
|
|
| Primary | Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | 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. | 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). | Posted | Mean | Standard Deviation | months | Up to 15 years prior to baseline |
|
|
|
|
| Primary | Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA | 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. | 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). | Posted | Mean | Standard Deviation | months | Baseline, Up to 60 months post-baseline |
|
|
|
|
| Secondary | 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) | 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. | 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. | Posted | Mean | Standard Deviation | months | Up to 15 years prior to baseline |
|
|
|
|
| Secondary | Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas | 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. | 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). | Posted | Mean | Standard Deviation | months | Baseline, Up to 60 months post-baseline |
|
|
|
| Secondary | Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event | 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). | 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). | Posted | Median | Full Range | months | Up to 15 years prior to baseline |
|
|
|
|
| Secondary | Time From Start of Study Follow-up to Time of First FAP-related Adverse Event | 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). | 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. | Posted | Median | Full Range | months | Baseline, Up to 60 months post-baseline |
|
|
|
| Secondary | Time From Post IRA to Time of Conversion From IRA to IPAA | Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44. | All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data). | Posted | Median | Full Range | months | Up to 15 years prior to baseline |
|
|
|
| Secondary | Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA | Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44. | 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). | Posted | Median | Full Range | months | Baseline, Up to 60 months post-baseline |
|
|
|
| Post-Hoc | Duodenal Adenoma Burden as Measured by Polyp Counts | 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) | 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. | Posted | Number | participants | Baseline, 6 to 14 months post-baseline, End of study (EOS) |
|
|
|
| Secondary | Duodenal Adenoma Burden as Measured by Spigelman Stage | 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. | All subjects; Spigelman Stage not completed as staging data largely missing. | Posted | Baseline, 6 to 14 months post-baseline, End of study (EOS) |
|
|
| Secondary | Rectal or Pouch Adenoma Burden Based on Polyp Counts | 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). | All subjects; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers. | Posted | Number | particpants | Baseline, 6 to 14 months post-baseline, EOS |
|
|
|
| 5 |
| 54 |
| 0 |
| 54 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
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.
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Kaplan-Meier Estimate of Time to Event |
| 19.81 |
| 95 |
| 0.00 |
| 33.77 |
Kaplan-Meier Estimate of Time to Event (months). |
| Superiority or Other (legacy) |
| Time to FAP-related surgical events (months); 25th percentile. | Kaplan-Meier Estimate of Time to Event | 169.94 | 95 | 104.73 | 183.48 | Kaplan-Meier Estimate of Time to Event (months). | Superiority or Other (legacy) |
| Kaplan-Meier Estimate of Time to Event |
| 40.21 |
| 95 |
| 8.31 |
| 105.68 |
Kaplan-Meier Estimate of Time to Event (months). |
| Superiority or Other (legacy) |
| Time to FAP-related surgical events (months); 25th percentile. | Kaplan-Meier Estimate of Time to Event | 19.81 | 95 | 16.03 | 56.34 | Kaplan-Meier Estimate of Time to Event (months). | Superiority or Other (legacy) |
| Time to FAP-related surgical events (months); 25th percentile. | Kaplan-Meier Estimate of Time to Event | 20.22 | 95 | 12.35 | 40.31 | Kaplan-Meier Estimate of Time to Event (months). | Superiority or Other (legacy) |
| Kaplan-Meier Estimate of Time to Event |
| 19.81 |
| 95 |
| 3.68 |
| 64.16 |
Kaplan-Meier Estimate of Time to Event (months). |
| Superiority or Other (legacy) |
| Baseline mild |
|
| Baseline severe |
|
| Baseline unknown |
|
| Baseline no polyps |
|
| Baseline not assessed |
|
| Post-baseline attenuated |
|
| Post-baseline mild |
|
| Post-baseline severe |
|
| Post-baseline unknown |
|
| Post-baseline no polyps |
|
| Post-baseline not assessed |
|
| EOS attenuated |
|
| EOS mild |
|
| EOS severe |
|
| EOS unknown |
|
| EOS no polyps |
|
| EOS not assessed |
|
| Baseline mild |
|
| Baseline severe |
|
| Baseline unknown |
|
| Baseline no polyps |
|
| Baseline not assessed |
|
| Post-baseline attenuated |
|
| Post-baseline mild |
|
| Post-baseline severe |
|
| Post-baseline unknown |
|
| Post-baseline no polyps |
|
| Post-baseline not assessed |
|
| EOS attenuated |
|
| EOS mild |
|
| EOS severe |
|
| EOS unknown |
|
| EOS no polyps |
|
| EOS not assessed |
|