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| Name | Class |
|---|---|
| JSS Medical Research Inc. | INDUSTRY |
| CMX Research | OTHER |
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The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.
This is a Canadian Post Marketing Observational Study utilizing a prospective cohort design. Patients with Prostate Cancer who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 36 months with recommended assessments at 3, 6, 12, 18, 24, 30 and 36 months after baseline. Treatment of the patients and follow up will be according to the physician's judgment, regional regulations and the product monograph.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Prostate Cancer | Patients with prostate cancer who were receiving treatment with leuprolide acetate (Lupron). |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0 | PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA > 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. | 36 months |
| Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests | A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA > 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Castration Resistant Prostate Cancer (CRPC): Number of Participants | CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. | 36 months |
| Castration Resistant Prostate Cancer (CRPC): Time to Event |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be enrolled from the offices of university or community urologists/oncologists across Canada treating patients with PCa.
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| Name | Affiliation | Role |
|---|---|---|
| Christina Pelizon, MD | AbbVie Corporation | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Prostate Cancer | Patients with prostate cancer who were receiving treatment with Lupron. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Prostate Cancer | Patients with prostate cancer who were receiving treatment with Lupron. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0 | PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA > 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. | Posted | Mean | Standard Error | months | 36 months |
|
Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Prostate Cancer | Patients with prostate cancer who were receiving treatment with Lupron. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOCYTE VACUOLISATION | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
This was a real-world evidence assessment with clear limitations. One of the key limitations of the study was that treatment patterns were not fully documented. Furthermore, compliance/adherence may have impacted efficacy data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.
| 36 months |
| Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, > 0.7 to ≤ 1.7 nmol/L, and > 1.7 nmol/L are provided at each time point. | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
| Total Serum Testosterone Levels at Each Visit | Total serum testosterone was assessed at each study visit. | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
| Total Serum Testosterone: Time to Increase Over Castrate Levels | Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. | 36 months |
| Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Serum PSA was assessed at each study visit. The percentage of participants with serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL are provided at each time point. | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
| Prostatic Specific Antigen (PSA) Levels at Each Visit | Serum PSA was assessed at each study visit. | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
| Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction. | Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
| Treatment Compliance | Treatment compliance by participants was assessed as the number of missed injections since the last visit. | Months 3, 6, 12, 18, 24, 30, and 36 |
| Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Participants were asked "Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?"; if Yes, was the change "Initiation of new mediation/Change in Dose/Frequency" or "Discontinuation of medication". The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented. | Months 3, 6, 12, 18, 24, 30, and 36 |
| Withdrawal of Consent |
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| Alternative Therapy Required |
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| Disease Progression |
|
| Adverse Event |
|
| Noncompliance |
|
| Protocol Violation |
|
| Missing |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests | A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA > 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. | Posted | Mean | Standard Error | months | 36 months |
|
|
|
| Secondary | Castration Resistant Prostate Cancer (CRPC): Number of Participants | CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. | All participants who achieved PSA levels ≤ 2 ng/mL | Posted | Number | participants | 36 months |
|
|
|
| Secondary | Castration Resistant Prostate Cancer (CRPC): Time to Event | CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided. | All participants who achieved PSA levels ≤2 ng/mL | Posted | Mean | Standard Error | months | 36 months |
|
|
|
| Secondary | Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit | Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, > 0.7 to ≤ 1.7 nmol/L, and > 1.7 nmol/L are provided at each time point. | All participants with available data at given time point. | Posted | Number | percentage of participants | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Total Serum Testosterone Levels at Each Visit | Total serum testosterone was assessed at each study visit. | All participants with available data at given time point. | Posted | Mean | Standard Deviation | nmol/L | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Total Serum Testosterone: Time to Increase Over Castrate Levels | Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided. | All participants who achieved castrate testosterone levels (≤1.7 nmol/L) | Posted | Mean | Standard Error | months | 36 months |
|
|
|
| Secondary | Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit | Serum PSA was assessed at each study visit. The percentage of participants with serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL are provided at each time point. | All participants with available date at given time point | Posted | Number | percentage of participants | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Prostatic Specific Antigen (PSA) Levels at Each Visit | Serum PSA was assessed at each study visit. | All participants with available data at given time point. | Posted | Mean | Standard Deviation | ng/ml | Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit | The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL. | Posted | Mean | Standard Error | units on a scale | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit | The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL. | Posted | Mean | Standard Error | units on a scale | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit | IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction. | Posted | Mean | Standard Error | units on a scale | Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36 |
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|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with available data at given time point. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants who had visited a physician and with available data at given time point. | Posted | Mean | Standard Deviation | physician visits | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants who had visited a healthcare professional and with available data at given time point. | Posted | Mean | Standard Deviation | healthcare professional visits | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants who had visited a hospital emergency room and with available data at given time point. | Posted | Mean | Standard Deviation | hospital emergency room visits | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants who had used an ambulance service and with available data at given time point. | Posted | Mean | Standard Deviation | ambulance service uses | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants who had visited complementary/alternate therapy and with available data at given time point. | Posted | Mean | Standard Deviation | complementary/alternate therapy visits | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants who had visited for any other medical service and with available data at given time point. | Posted | Mean | Standard Deviation | visits for any other medical service | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | Posted | Count of Participants | Participants | No | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants who were admitted to the hospital and with available data at given time point. | Posted | Mean | Standard Deviation | admissions to the hospital | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with out of pocket expenses for over-the-counter medications and with available data at given time point. | Posted | Mean | Standard Deviation | dollars (CAD) | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with out of pocket expenses for payments to health care professionals and with available data at given time point. | Posted | Mean | Standard Deviation | dollars (CAD) | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with out of pocket expenses for medical procedures and with available data at given time point. | Posted | Mean | Standard Deviation | dollars (CAD) | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with out of pocket expenses for payments for medical procedures or laboratory tests and with available data at given time point. | Posted | Mean | Standard Deviation | dollars (CAD) | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with out of pocket expenses for medical devices and with available data at given time point. | Posted | Mean | Standard Deviation | dollars (CAD) | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with out of pocket expenses for health care or extra help at home and with available data at given time point. | Posted | Mean | Standard Deviation | dollars (CAD) | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer | The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care. | All participants with out of pocket expenses for transportation costs and with available data at given time point. | Posted | Mean | Standard Deviation | dollars (CAD) | Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Treatment Compliance | Treatment compliance by participants was assessed as the number of missed injections since the last visit. | All participants with available data at given time point. | Posted | Mean | Standard Deviation | missed injections | Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| Secondary | Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit. | Participants were asked "Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?"; if Yes, was the change "Initiation of new mediation/Change in Dose/Frequency" or "Discontinuation of medication". The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented. | The number of participants with changes in current prostate cancer treatment since the last visit at given time point. | Posted | Number | percentage of participants | Months 3, 6, 12, 18, 24, 30, and 36 |
|
|
|
| 132 |
| 552 |
| 77 |
| 552 |
| BANDAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ANGINA UNSTABLE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| AORTIC VALVE STENOSIS | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BUNDLE BRANCH BLOCK RIGHT | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CARDIAC DISORDER | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CARDIOMEGALY | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ISCHAEMIC CARDIOMYOPATHY | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LEFT VENTRICULAR HYPERTROPHY | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEAFNESS | Ear and labyrinth disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIPLOPIA | Eye disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OCULAR MYASTHENIA | Eye disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ABDOMINAL MASS | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| COELIAC DISEASE | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIARRHOEA HAEMORRHAGIC | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIVERTICULUM | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INTESTINAL MASS | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NEUTROPENIC COLITIS | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CHILLS | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CONDITION AGGRAVATED | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEATH | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DRUG INEFFECTIVE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GAIT DISTURBANCE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| IMPAIRED SELF-CARE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INFLAMMATION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LOCAL SWELLING | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MALAISE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NO THERAPEUTIC RESPONSE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OBSTRUCTION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PAIN | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PELVIC MASS | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| UNEVALUABLE EVENT | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HEPATIC LESION | Hepatobiliary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| IMMUNOSUPPRESSION | Immune system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| ENDOCARDITIS BACTERIAL | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| GASTROENTERITIS ESCHERICHIA COLI | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| ANAESTHETIC COMPLICATION | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| TRACHEOSTOMY MALFUNCTION | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| TRAUMATIC LUNG INJURY | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY RETENTION POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| BLOOD ALBUMIN DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| BLOOD URINE PRESENT | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| BRAIN NATRIURETIC PEPTIDE INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| EJECTION FRACTION ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| EXERCISE ELECTROCARDIOGRAM ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| OXYGEN SATURATION DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATIC SPECIFIC ANTIGEN INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| SCAN MYOCARDIAL PERFUSION ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| STAPHYLOCOCCUS TEST POSITIVE | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| TROPONIN INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| VENOUS PRESSURE JUGULAR INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| ACIDOSIS | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BILIARY NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| CHOLESTEATOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| CHRONIC LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| COLON CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| COLON NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| GASTROINTESTINAL STROMAL TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| HIGH GRADE B-CELL LYMPHOMA BURKITT-LIKE LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| HORMONE-REFRACTORY PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| LUNG ADENOCARCINOMA STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| MESOTHELIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTASES TO RECTUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTASIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| PLASMA CELL MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATE CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATE CANCER STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF PHARYNX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| BALANCE DISORDER | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CAUDA EQUINA SYNDROME | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| COMA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEMENTIA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| UNRESPONSIVE TO STIMULI | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEVICE OCCLUSION | Product Issues | MedDRA (19.1) | Non-systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DELUSION | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DISORIENTATION | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PARANOIA | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CALCULUS BLADDER | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INCONTINENCE | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INTERCAPILLARY GLOMERULOSCLEROSIS | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OBSTRUCTIVE UROPATHY | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RENAL CYST | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY BLADDER HAEMORRHAGE | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATIC OBSTRUCTION | Reproductive system and breast disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ALVEOLITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BRONCHIAL HYPERREACTIVITY | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| COLD SWEAT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ACTIVITIES OF DAILY LIVING IMPAIRED | Social circumstances | MedDRA (19.1) | Non-systematic Assessment |
|
| BLADDER CALCULUS REMOVAL | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
|
| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
|
| HYDROCELE OPERATION | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
|
| STERNOTOMY | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
|
| TRANSURETHRAL PROSTATECTOMY | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY CYSTECTOMY | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
|
| ANGIOPATHY | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| AORTIC STENOSIS | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BLEEDING VARICOSE VEIN | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OCULAR MYASTHENIA | Eye disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CHEST DISCOMFORT | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CHILLS | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DRUG INEFFECTIVE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GAIT DISTURBANCE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INJECTION SITE PAIN | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INJECTION SITE SWELLING | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| INJECTION SITE ULCER | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MALAISE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NODULE | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PAIN | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HEPATIC LESION | Hepatobiliary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSENTERY | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY TRACT INFECTION ENTEROCOCCAL | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| RADIATION ASSOCIATED PAIN | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (19.1) | Non-systematic Assessment |
|
| BLOOD CREATININE ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| BLOOD TESTOSTERONE | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| BLOOD TESTOSTERONE INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| GLYCOSYLATED HAEMOGLOBIN INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMOGLOBIN ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| NEUTROPHIL TOXIC GRANULATION PRESENT | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| OXYGEN SATURATION DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATIC SPECIFIC ANTIGEN INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT ABNORMAL | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| CACHEXIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| FLUID INTAKE REDUCED | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOPHAGIA | Metabolism and nutrition disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BONE LESION | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| JOINT DESTRUCTION | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| WEIGHT BEARING DIFFICULTY | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| METASTATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATE CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Non-systematic Assessment |
|
| DEMENTIA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NEURALGIA | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| EMOTIONAL DISORDER | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| EUPHORIC MOOD | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LISTLESS | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PSYCHIATRIC DECOMPENSATION | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NOCTURIA | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PROSTATIC OBSTRUCTION | Reproductive system and breast disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RALES | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ACTIVITIES OF DAILY LIVING IMPAIRED | Social circumstances | MedDRA (19.1) | Non-systematic Assessment |
|
| RADIOTHERAPY TO PROSTATE | Surgical and medical procedures | MedDRA (19.1) | Non-systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HAEMODYNAMIC INSTABILITY | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| PALLOR | Vascular disorders | MedDRA (19.1) | Non-systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| Month 6: ≤ 0.7 nmol/L |
|
|
| Month 12: ≤ 0.7 nmol/L |
|
|
| Month 18: ≤ 0.7 nmol/L |
|
|
| Month 24: ≤ 0.7 nmol/L |
|
|
| Month 30: ≤ 0.7 nmol/L |
|
|
| Month 36: ≤ 0.7 nmol/L |
|
|
| Month 0: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 3: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 6: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 12: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 18: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 24: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 30: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 36: > 0.7 to ≤ 1.7 nmol/L |
|
|
| Month 0: > 1.7 nmol/L |
|
|
| Month 3: > 1.7 nmol/L |
|
|
| Month 6: > 1.7 nmol/L |
|
|
| Month 12: > 1.7 nmol/L |
|
|
| Month 18: > 1.7 nmol/L |
|
|
| Month 24: > 1.7 nmol/L |
|
|
| Month 30: > 1.7 nmol/L |
|
|
| Month 36: > 1.7 nmol/L |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6: <1 ng/mL |
|
|
| Month 12: <1 ng/mL |
|
|
| Month 18: <1 ng/mL |
|
|
| Month 24: <1 ng/mL |
|
|
| Month 30: <1 ng/mL |
|
|
| Month 36: <1 ng/mL |
|
|
| Month 0: 1 to <5 ng/mL |
|
|
| Month 3: 1 to <5 ng/mL |
|
|
| Month 6: 1 to <5 ng/mL |
|
|
| Month 12: 1 to <5 ng/mL |
|
|
| Month 18: 1 to <5 ng/mL |
|
|
| Month 24: 1 to <5 ng/mL |
|
|
| Month 30: 1 to <5 ng/mL |
|
|
| Month 36: 1 to <5 ng/mL |
|
|
| Month 0: 5 to <10 ng/mL |
|
|
| Month 3: 5 to <10 ng/mL |
|
|
| Month 6: 5 to <10 ng/mL |
|
|
| Month 12: 5 to <10 ng/mL |
|
|
| Month 18: 5 to <10 ng/mL |
|
|
| Month 24: 5 to <10 ng/mL |
|
|
| Month 30: 5 to <10 ng/mL |
|
|
| Month 36: 5 to <10 ng/mL |
|
|
| Month 0: ≥10 ng/mL |
|
|
| Month 3: ≥10 ng/mL |
|
|
| Month 6: ≥10 ng/mL |
|
|
| Month 12: ≥10 ng/mL |
|
|
| Month 18: ≥10 ng/mL |
|
|
| Month 24: ≥10 ng/mL |
|
|
| Month 30: ≥10 ng/mL |
|
|
| Month 36: ≥10 ng/mL |
|
|
| Title | Measurements |
|---|---|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Title | Measurements |
|---|---|
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
| Title | Measurements |
|---|---|
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
| Title | Measurements |
|---|---|
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
| Month 30 |
|
|
| Month 36 |
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
| Month 6 |
|
|
| Month 12 |
|
| Month 18 |
|
|
| Month 24 |
|
| Month 30 |
|
|
| Month 36 |
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
|
| Month 6 |
|
| Month 12 |
|
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
|
| Title | Measurements |
|---|
|
| Month 12 |
|
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 |
|
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| Month 12 |
|
|
| Month 18 |
|
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| Month 24 |
|
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| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 |
|
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| Month 12 |
|
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| Month 18 |
|
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| Month 24 |
|
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| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
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| Month 36 |
|
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
|
| Month 6 Initiation or Change in Dose/Frequency |
|
|
| Month 6 Discontinuation of Medication |
|
|
| Month 12 Initiation or Change in Dose/Frequency |
|
|
| Month 12 Discontinuation of Medication |
|
|
| Month 18 Initiation or Change in Dose/Frequency |
|
|
| Month 18 Discontinuation of Medication |
|
|
| Month 24 Initiation or Change in Dose/Frequency |
|
|
| Month 24 Discontinuation of Medication |
|
|
| Month 30 Initiation or Change in Dose/Frequency |
|
|
| Month 30 Discontinuation of Medication |
|
|
| Month 36 Initiation or Change in Dose/Frequency |
|
|
| Month 36 Discontinuation of Medication |
|
|