Cancer
Conditions
Keywords
New Incidence of Cancer
Brief summary
The purpose of this extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period in patients from the SEAS trial (2004\_050, MK0653A-043; NCT00092677).
Detailed description
The SEAS Follow-up Study is a 21 month extension to the base protocol (2004\_050, MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial. The sources of study data will include data collected from national cancer and death registries as well as data from the original clinical trial. No patient visits will occur. National cancer and death registries exist in 5 of the 7 countries that participated in the base SEAS trial. At the time of Follow-up study initiation, accessing the registry data in Ireland was not feasible due to local regulations and Cancer and Death registries did not exist in Germany. As a result, data will be collected only for all SEAS patients known to be alive at the end of the base study originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.
Interventions
None listed
Sponsors
Institute of Applied Economics Aps, Denmark
Organon and Co
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The cohort will include all patients from the five participating countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base study and who were known to be alive at the end of the base study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort | up to 21 Months after the end of the SEAS (base) study | Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crude Rate of Death (Any Cause) - Follow-up Total Cohort | up to 21 Months after the end of the base study | All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death. |
| Crude Rate of Death Due to Cancer - Follow-up Primary Cohort | up to 21 Months after the end of the base study | All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer. |
Participant flow
Recruitment details
All participants from five countries (Sweden, Denmark, Norway, Finland, and United Kingdom) who completed the SEAS base study and who were known to be alive at the end of the base study.
Pre-assignment details
Of the 1873 participants in the SEAS base study, 1392 were eligible for inclusion in this follow-up study. Of these 1392 participants, 33 were excluded due to incomplete base study data or because follow-up data could not be obtained, leaving 1359 participants in the follow-up study.
Participants by arm
| Arm | Count |
|---|---|
| Ezetimibe/Simvastatin 10/40 mg Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study | 677 |
| Placebo Participants who received placebo in the base study | 682 |
| Total | 1,359 |
Baseline characteristics
| Characteristic | Total | Ezetimibe/Simvastatin 10/40 mg | Placebo |
|---|---|---|---|
| Age, Customized 50 to 59 years | 183 Participants | 92 Participants | 91 Participants |
| Age, Customized < 50 years | 7 Participants | 4 Participants | 3 Participants |
| Age, Customized 60 to 69 years | 349 Participants | 160 Participants | 189 Participants |
| Age, Customized 70 to 79 years | 484 Participants | 250 Participants | 234 Participants |
| Age, Customized ≥80 years | 336 Participants | 171 Participants | 165 Participants |
| Sex: Female, Male Female | 539 Participants | 267 Participants | 272 Participants |
| Sex: Female, Male Male | 820 Participants | 410 Participants | 410 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort
Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.
Time frame: up to 21 Months after the end of the SEAS (base) study
Population: Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe/Simvastatin 10/40 mg | Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort | 1.14 per 100 participant-years |
| Placebo | Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort | 2.07 per 100 participant-years |
95% CI: [0.27, 1.11]
Secondary
Crude Rate of Death (Any Cause) - Follow-up Total Cohort
All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.
Time frame: up to 21 Months after the end of the base study
Population: Primary analysis population was Follow-Up Total Cohort defined as all participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe/Simvastatin 10/40 mg | Crude Rate of Death (Any Cause) - Follow-up Total Cohort | 3.59 per 100 participant-years |
| Placebo | Crude Rate of Death (Any Cause) - Follow-up Total Cohort | 2.70 per 100 participant-years |
95% CI: [0.84, 2.09]Regression, Cox
Secondary
Crude Rate of Death Due to Cancer - Follow-up Primary Cohort
All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.
Time frame: up to 21 Months after the end of the base study
Population: Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe/Simvastatin 10/40 mg | Crude Rate of Death Due to Cancer - Follow-up Primary Cohort | 0.38 per 100 participant-years |
| Placebo | Crude Rate of Death Due to Cancer - Follow-up Primary Cohort | 0.28 per 100 participant-years |
95% CI: [0.3, 6.06]