Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 64091742PCR2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-002057-38 | EudraCT Number |
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The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
This is a multicenter and open-label (participants and researchers are aware of the treatment that participants are receiving) study that consists of 4 phases: a Prescreening Phase for biomarker evaluation only, a Screening Phase, a Treatment Phase (Cycle 1 Day 1 and will continue until the study drug is discontinued), a Follow-up Phase (every 3 months after end of treatment visit), and a Long-term Extension Phase (until participants no longer derive benefit from treatment or until further notification on different means of study treatment). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib | Experimental | Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation | ORR defined as percentage of participants with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria. | Up to 52 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation | ORR defined as percentage of participants with BRCA deoxyribonucleic acid (DNA)-repair anomalies and measurable disease whose best response is either CR or PR per RECIST 1.1 and with no evidence of bone progression per PCWG3 criteria. | Up to 52 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37404070 | Derived | Smith MR, Sandhu S, George DJ, Chi KN, Saad F, Thiery-Vuillemin A, Stahl O, Olmos D, Danila DC, Gafanov R, Castro E, Moon H, Joshua AM, Mason GE, Espina BM, Liu Y, Lopez-Gitlitz A, Francis P, Bevans KB, Fizazi K. Health-related quality of life in GALAHAD: A multicenter, open-label, phase 2 study of niraparib for patients with metastatic castration-resistant prostate cancer and DNA-repair gene defects. J Manag Care Spec Pharm. 2023 Jul;29(7):758-768. doi: 10.18553/jmcp.2023.29.7.758. | |
| 35131040 |
Not provided
Not provided
For long-term extension (LTE) phase, as pre planned in the protocol no efficacy analysis was performed. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Niraparib | Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2020 | Aug 13, 2024 |
Not provided
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| Circulating Tumor Cells (CTC) Response Rate | CTC response rate was defined as the percentage of participants with CTC equals to (=) 0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0. | At 8 weeks post-baseline |
| Overall Survival (OS) | OS is defined as time from enrollment to death from any cause. | Up to 52 months |
| Radiographic Progression-Free Survival (rPFS) | rPFS was defined as time from enrollment to radiographic progression or death from any cause, whichever occurred first. Radiographic progression was evaluated per RECIST 1.1 criteria for soft tissue disease and per PCWG3 criteria for bone disease. | Up to 52 months |
| Time to Radiographic Progression | Time to radiographic progression is defined as time from enrollment to radiographic progression or death due to disease progression, whichever occurs first. Disease progression is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | Up to 52 months |
| Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression was defined as time from enrollment to the first date of documented PSA progression based on PCWG3 criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanograms per milliliter (ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. | Up to 52 months |
| Time to Symptomatic Skeletal Event (SSE) | Time to SSE was defined as the time from enrollment to first occurrence of one of the following symptomatic skeletal events: tumor-related spinal cord compression, radiation to bone to relieve skeletal symptoms, surgery to bone or need for tumor-related orthopedic surgical intervention, symptomatic or pathologic fracture. | Up to 52 months |
| Duration of Objective Response | Duration of objective response is defined as time from CR or PR to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first. Unequivocal clinical progression defined as one or more of following: 1) deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) to Grade 3 or higher; 2) need to initiate any of following because of tumor progression (even in absence of radiographic evidence of disease): alternative anticancer therapy for prostate cancer, radiation therapy, surgical interventions for complications due to tumor progression. | Up to 52 months |
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. | Up to 52 months |
| Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) | Number of participants with worst toxicity grades for clinical laboratory tests (chemistry and hematology) based on NCI-CTCAE were reported. The chemistry laboratory parameters were: alanine aminotransferase (ALT) increased, alkaline phosphatase increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine increased, gamma glutamyl transferase (GGT) increased and the hematology parameters were: hemoglobin increased, lymphocyte count increased. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). | Up to 52 months |
| Los Angeles |
| California |
| United States |
| Riverside | California | United States |
| Sacramento | California | United States |
| Aurora | Colorado | United States |
| Denver | Colorado | United States |
| Evanston | Illinois | United States |
| Danville | Kentucky | United States |
| Louisville | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | United States |
| Omaha | Nebraska | United States |
| New York | New York | United States |
| Durham | North Carolina | United States |
| Lancaster | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Myrtle Beach | South Carolina | United States |
| Houston | Texas | United States |
| Charlottesville | Virginia | United States |
| Fairfax | Virginia | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| Camperdown | Australia |
| Darlinghurst | Australia |
| East Albury | Australia |
| Kurralta Park | Australia |
| Macquarie University | Australia |
| Melbourne | Australia |
| Murdoch | Australia |
| Port Macquarie | Australia |
| Randwick | Australia |
| Wahroonga | Australia |
| Aalst | Belgium |
| Brussels | Belgium |
| Charleroi | Belgium |
| Ghent | Belgium |
| Haine-Saint-Paul | Belgium |
| Hasselt | Belgium |
| Kortrijk | Belgium |
| Liège | Belgium |
| Namur | Belgium |
| Ottignies | Belgium |
| Wilrijk | Belgium |
| Barretos | Brazil |
| Belo Horizonte | Brazil |
| Curitiba | Brazil |
| Fortaleza | Brazil |
| Ijuà | Brazil |
| Itajaà | Brazil |
| Joinville | Brazil |
| Natal | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| Vancouver | British Columbia | Canada |
| Oshawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Aarhus N | Denmark |
| Copenhagen N | Denmark |
| Herlev | Denmark |
| Odense C | Denmark |
| Avignon | France |
| Besançon | France |
| Caen | France |
| Lyon | France |
| Nice | France |
| Paris | France |
| Reims | France |
| Strasbourg | France |
| Villejuif | France |
| Beersheba | Israel |
| Haifa | Israel |
| Kfar Saba | Israel |
| Ramat Gan | Israel |
| Zrifin | Israel |
| Alkmaar | Netherlands |
| Amsterdam | Netherlands |
| Groningen | Netherlands |
| Maastricht | Netherlands |
| Rotterdam | Netherlands |
| Moscow | Russia |
| Omsk | Russia |
| Tomsk | Russia |
| Seoul | South Korea |
| Barcelona | Spain |
| Córdoba | Spain |
| Madrid | Spain |
| Málaga | Spain |
| Pozuelo de Alarcón | Spain |
| Santander | Spain |
| Santiago de Compostela | Spain |
| Seville | Spain |
| Valencia | Spain |
| Gothenburg | Sweden |
| Lund | Sweden |
| Stockholm | Sweden |
| Umeå | Sweden |
| Kaohsiung City | Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Taoyuan County | Taiwan |
| Blackburn | United Kingdom |
| Bristol | United Kingdom |
| Cardiff | United Kingdom |
| Exeter | United Kingdom |
| London | United Kingdom |
| Preston | United Kingdom |
| Derived |
| Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Stahl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4. |
| Intent to Treat Participants (Breast Cancer Gene [BRCA] and Non-BRCA Participants) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Niraparib | Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation | ORR defined as percentage of participants with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria. | Measurable intent to treat (ITT) population also referred to as efficacy analysis set included all participants who received at least 1 dose of study drug and have BRCA (biallelic or germline DNA-repair anomalies) and measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 52 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation | ORR defined as percentage of participants with BRCA deoxyribonucleic acid (DNA)-repair anomalies and measurable disease whose best response is either CR or PR per RECIST 1.1 and with no evidence of bone progression per PCWG3 criteria. | Measurable ITT analysis set included all participants who received at least 1 dose of study drug and have non-BRCA (biallelic DNA-repair anomaly) and measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 52 months |
| |||||||||||||||||||||||||||
| Secondary | Circulating Tumor Cells (CTC) Response Rate | CTC response rate was defined as the percentage of participants with CTC equals to (=) 0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0. | ITT analysis set included all participants who received at least 1 dose of study drug. Here 'N' (number of participants analysed) specifies the participants with baseline CTC (per 7.5 mL blood) > 0. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Number | percentage of participants | At 8 weeks post-baseline |
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as time from enrollment to death from any cause. | ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Median | 95% Confidence Interval | months | Up to 52 months |
|
| ||||||||||||||||||||||||||
| Secondary | Radiographic Progression-Free Survival (rPFS) | rPFS was defined as time from enrollment to radiographic progression or death from any cause, whichever occurred first. Radiographic progression was evaluated per RECIST 1.1 criteria for soft tissue disease and per PCWG3 criteria for bone disease. | ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Median | 95% Confidence Interval | months | Up to 52 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Radiographic Progression | Time to radiographic progression is defined as time from enrollment to radiographic progression or death due to disease progression, whichever occurs first. Disease progression is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Median | 95% Confidence Interval | months | Up to 52 months |
| |||||||||||||||||||||||||||
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression was defined as time from enrollment to the first date of documented PSA progression based on PCWG3 criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanograms per milliliter (ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. | ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Median | 95% Confidence Interval | months | Up to 52 months |
| |||||||||||||||||||||||||||
| Secondary | Time to Symptomatic Skeletal Event (SSE) | Time to SSE was defined as the time from enrollment to first occurrence of one of the following symptomatic skeletal events: tumor-related spinal cord compression, radiation to bone to relieve skeletal symptoms, surgery to bone or need for tumor-related orthopedic surgical intervention, symptomatic or pathologic fracture. | ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Median | 95% Confidence Interval | months | Up to 52 months |
| |||||||||||||||||||||||||||
| Secondary | Duration of Objective Response | Duration of objective response is defined as time from CR or PR to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first. Unequivocal clinical progression defined as one or more of following: 1) deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) to Grade 3 or higher; 2) need to initiate any of following because of tumor progression (even in absence of radiographic evidence of disease): alternative anticancer therapy for prostate cancer, radiation therapy, surgical interventions for complications due to tumor progression. | Measurable ITT responder analysis set included all participants who received at least 1 dose of study drug, responded to it and have BRCA or non-BRCA and measurable disease at baseline. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Median | 95% Confidence Interval | months | Up to 52 months |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 52 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) | Number of participants with worst toxicity grades for clinical laboratory tests (chemistry and hematology) based on NCI-CTCAE were reported. The chemistry laboratory parameters were: alanine aminotransferase (ALT) increased, alkaline phosphatase increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine increased, gamma glutamyl transferase (GGT) increased and the hematology parameters were: hemoglobin increased, lymphocyte count increased. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). | Safety analysis set included all participants who received at least 1 dose of study drug and with at least one postbaseline assessment for the specific lab test within the time period. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. | Posted | Count of Participants | Participants | Up to 52 months |
|
Up to 52 months
Safety analysis set included all participants who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Niraparib | Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (based (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy milligrams chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (or(mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination subjects termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator's discretion until no benefits from treatment or Sponsor's decision. | 208 | 289 | 134 | 289 | 280 | 289 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Acute Abdomen | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Inflammatory Bowel Disease | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Facial Pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abscess Jaw | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Infected Lymphocele | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia Haemophilus | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Spinal Cord Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cystitis Radiation | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Extradural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood Calcium Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal Stromal Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Metastases to Meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Altered State of Consciousness | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cauda Equina Syndrome | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nerve Compression | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EXECUTIVE MEDICAL DIRECTOR | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2021 | Aug 13, 2024 | SAP_003.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C545685 | niraparib |
Not provided
Not provided
Not provided
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| BRAZIL |
|
| CANADA |
|
| DENMARK |
|
| FRANCE |
|
| ISRAEL |
|
| NETHERLANDS |
|
| RUSSIAN FEDERATION |
|
| SOUTH KOREA |
|
| SPAIN |
|
| SWEDEN |
|
| TAIWAN |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
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