Trial · NCT01234350
A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
NCT01234350, Completed, Ferring Pharmaceuticals; results first posted 2019-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON. Trials, record NCT01234350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01234350
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
- NCT number
- NCT01234350
- Status
- Completed
- Enrollment
- 1,493 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Prostate Cancer
- First posted
- 2010-11-04
- Last updated
- 2019-06-25
- Results first posted
- 2019-05-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE). |
| Primary | Incidence Rate of AESI: Decreased Bone Density | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE. |
| Primary | Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE. Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L |
| Primary | Change in Hepatic Enzymes | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | Change from baseline in hepatic enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase \[ALP\]) are presented. |
| Primary | Change in Hepatic Enzymes | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | Change from baseline in hepatic enzyme level (bilirubin) is presented. |
| Primary | Change in Serum Glucose | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | Change from baseline in serum glucose are presented. |
| Secondary | Number and Classification of New Adverse Drug Reactions (ADRs) | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | An ADR was defined as an AE assessed by investigator as possibly/probably related to the investigational product. Any new potentially unrecognized ADRs were presented. |
| Secondary | Long Term Evaluation of Clinical Evolution of Prostate Cancer | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | Change in prostate specific antigen (PSA) is presented. |
| Secondary | Changes in Testosterone Levels | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | Change from baseline in testosterone levels are presented. |
| Secondary | All-cause of Mortality | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | A summary of IRs of all-cause mortality is presented. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | Events per 100 PYE | NUMBER |
| PRIMARY | Incidence Rate of AESI: Decreased Bone Density | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | Events per 100 PYE | NUMBER |
| PRIMARY | Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | Events per 100 PYE | NUMBER |
| PRIMARY | Change in Hepatic Enzymes | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | IU/L | MEDIAN |
| PRIMARY | Change in Hepatic Enzymes | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | umol/L | MEDIAN |
| PRIMARY | Change in Serum Glucose | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | mmol/L | MEDIAN |
| SECONDARY | Number and Classification of New Adverse Drug Reactions (ADRs) | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | New ADR | NUMBER |
| SECONDARY | Long Term Evaluation of Clinical Evolution of Prostate Cancer | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | ng/mL | MEDIAN |
| SECONDARY | Changes in Testosterone Levels | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | ng/mL | MEDIAN |
| SECONDARY | All-cause of Mortality | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first). | Events per 100 PYE | NUMBER |
Source ClinicalTrials.gov
Results by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events | FIRMAGON | 3.8 | Events per 100 PYE | ||
| Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events | GnRH Agonist | 4.5 | Events per 100 PYE | ||
| Incidence Rate of AESI: Decreased Bone Density | FIRMAGON | Osteoporosis or Osteopenia | 1.1 | Events per 100 PYE | |
| Incidence Rate of AESI: Decreased Bone Density | GnRH Agonist | Osteoporosis or Osteopenia | 1.4 | Events per 100 PYE | |
| Incidence Rate of AESI: Decreased Bone Density | FIRMAGON | Bone fracture | 0.3 | Events per 100 PYE | |
| Incidence Rate of AESI: Decreased Bone Density | GnRH Agonist | Bone fracture | 0.1 | Events per 100 PYE | |
| Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) | FIRMAGON | Glucose intolerance | 15.3 | Events per 100 PYE | |
| Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) | GnRH Agonist | Glucose intolerance | 13.2 | Events per 100 PYE | |
| Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) | FIRMAGON | T2DM | 1.8 | Events per 100 PYE | |
| Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) | GnRH Agonist | T2DM | 0.7 | Events per 100 PYE |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FIRMAGON | 1,000 | |
| Overall Study | STARTED | GnRH Agonist | 493 | |
| Overall Study | COMPLETED | FIRMAGON | 313 | |
| Overall Study | COMPLETED | GnRH Agonist | 226 | |
| Overall Study | NOT COMPLETED | FIRMAGON | 687 | |
| Overall Study | NOT COMPLETED | GnRH Agonist | 267 |
Source ClinicalTrials.gov
Adverse events610
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | FIRMAGON | 100 | 1,000 | 226 |
| other | Injection site pain | General disorders | GnRH Agonist | 2 | 493 | 2 |
| other | Prostatic specific antigen increased | Investigations | FIRMAGON | 80 | 1,000 | 90 |
| other | Prostatic specific antigen increased | Investigations | GnRH Agonist | 26 | 493 | 29 |
| other | Hot flush | Vascular disorders | FIRMAGON | 166 | 1,000 | 172 |
| other | Hot flush | Vascular disorders | GnRH Agonist | 88 | 493 | 92 |
| serious | Anaemia | Blood and lymphatic system disorders | FIRMAGON | 6 | 1,000 | 9 |
| serious | Anaemia | Blood and lymphatic system disorders | GnRH Agonist | 10 | 493 | 13 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | FIRMAGON | 1 | 1,000 | 1 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | GnRH Agonist | 1 | 493 | 1 |
1 to 10 of 610Source ClinicalTrials.gov
See all 610 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FIRMAGON | 141 | 1,000 |
| Total, all-cause mortality | GnRH Agonist | 72 | 493 |
| Total, other adverse events | FIRMAGON | 294 | 1,000 |
| Total, other adverse events | GnRH Agonist | 110 | 493 |
| Total, serious adverse events | FIRMAGON | 236 | 1,000 |
| Total, serious adverse events | GnRH Agonist | 144 | 493 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FIRMAGON vs GnRH Agonist: deaths from any cause | Trial comparisons |
| FIRMAGON vs GnRH Agonist: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01234350
GET https://conductscience.org/api/trials/v1/NCT01234350/results?page=2