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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004429-17 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Abiraterone | Active Comparator | Participants received Placebo plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles. |
|
| Ipatasertib + Abiraterone | Experimental | Participants received Ipatasertib plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population | rPFS was defined as time from date of randomization to the first occurrence of documented disease progression (PD), as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm) in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The Kaplan-Meier (KM) estimate was used to determine the median rPFS. | Up to approximately 32 months |
| Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population | rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to RECIST v1.1 criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The KM estimate was used to determine the median rPFS. | Up to approximately 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in PTEN-loss Population | OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS. | Up to approximately 6.5 years |
| OS in ITT Population |
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Inclusion Criteria:
Disease-specific Inclusion Criteria:
Exclusion Criteria:
Disease-Specific Exclusion Criteria:
Abiraterone-Specific Exclusion Criteria:
Ipatasertib-Specific Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | United States | ||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36697317 | Derived | Matsubara N, de Bono J, Sweeney C, Chi KN, Olmos D, Sandhu S, Massard C, Garcia J, Chen G, Harris A, Schenkel F, Sane R, Hinton H, Bracarda S, Sternberg CN. Safety Profile of Ipatasertib Plus Abiraterone vs Placebo Plus Abiraterone in Metastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2023 Apr;21(2):230-237.e1. doi: 10.1016/j.clgc.2023.01.001. Epub 2023 Jan 7. | |
| 36305957 |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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Participants were randomized in a 1:1 ratio to one of the two following treatment arms: abiraterone plus prednisone/prednisolone plus ipatasertib (Ipat + Abi) and abiraterone plus prednisone/prednisolone plus placebo (Pbo + Abi). 3 participants in the Pbo+Abi arm and 1 participant in the Ipat +Abi arm did not receive any treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
A total of 1101 male participants with metastatic castrate-resistant prostate cancer (mCRPC) took part in the study at 181 investigative sites across 26 countries from June 30, 2017 to April 24, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pbo + Abi | Participants received matching placebo along with abiraterone 1000 milligrams (mg), once a day (QD) and prednisone/prednisolone, 5 mg, twice a day (BID) administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2022 | Apr 9, 2025 |
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| Abiraterone | Drug | Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water. |
|
| Placebo | Drug | Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity. |
|
| Prednisone/Prednisolone | Drug | Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity. |
|
OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS.
| Up to approximately 6.5 years |
| Time to Pain Progression in PTEN-loss Population | Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point numeric rating scale [NRS], with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression. | Up to approximately 5.5 years |
| Time to Pain Progression in ITT Population | Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point NRS, with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression. | Up to approximately 5.5 years |
| Time to Initiation of Cytotoxic Chemotherapy for Prostate Cancer (PC) in PTEN-loss Population | Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy. | Up to approximately 5.5 years |
| Time to Initiation of Cytotoxic Chemotherapy for PC in ITT Population | Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy. | Up to approximately 5.5 years |
| Time to Function Deterioration Per European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function (PF) Scale and Role Function (RF) Scale in PTEN-loss Population | Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive&social), 3 symptom scales (fatigue,nausea&vomiting,pain), global health/quality of life (GHS/QoL)&6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea&financial difficulties). PF scale has 5 questions about participants physical functioning&daily activities. RF scale has 2 questions about work/daily activities&hobbies/leisurely activities. PF&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF)&better functioning/support. | Up to approximately 5.5 years |
| Time to Function Deterioration Per EORTC QLQ-C30 PF Scale and RF Scale in ITT Population | Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive & social), 3 symptom scales (fatigue,nausea&vomiting,pain), GHS/QoL & 6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea & financial difficulties). PF scale has 5 questions about participants physical functioning & daily activities. RF scale has 2 questions about work/daily activities & hobbies/leisurely activities. PF&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF) & better functioning/support. | Up to approximately 5.5 years |
| Time to Prostate-specific Antigen (PSA) Progression, Per the PCWG3 Criteria in PTEN-loss Population | Time to PSA progression was defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression was defined as a PSA increase that was ≥ 25% and ≥ 2 nanograms per milliliters (ng/mL) above the baseline or the nadir, which was confirmed by a second value ≥ 3 weeks later. KM estimate was used to determine the median time to PSA. | Up to approximately 5.5 years |
| Time to PSA Progression, Per the PCWG3 Criteria in ITT Population | Time to PSA progression was defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression was defined as a PSA increase that was ≥ 25% and ≥ 2 ng/mL above the baseline or the nadir, which was confirmed by a second value ≥ 3 weeks later. KM estimate was used to determine the median time to PSA. | Up to approximately 5.5 years |
| Time to First Opioid Use in PTEN-loss Population | Time to first opioid use was defined as the time interval from the date of randomization to the date of an initiation of opioid analgesic use for cancer-related pain, and consumption reported on at least 7 consecutive days. KM estimate was used to determine the median time to first opioid use. | Up to approximately 5.5 years |
| Time to First Opioid Use in ITT Population | Time to first opioid use was defined as the time interval from the date of randomization to the date of an initiation of opioid analgesic use for cancer-related pain, and consumption reported on at least 7 consecutive days. KM estimate was used to determine the median time to first opioid use. | Up to approximately 5.5 years |
| Time to Symptomatic Skeletal Event (SSE) in PTEN-loss Population | Time to SSE was defined as the time from randomization to the first occurrence of an SSE. A SSE was defined using one of the following: use of external-beam radiotherapy to relieve skeletal symptoms (including initiation of radium-223 to treat symptoms of bone metastases); occurrence of a new symptomatic pathological bone fracture (vertebral or non-vertebral); clinically apparent occurrence of spinal cord compression, or a tumor-related orthopedic surgical intervention. KM estimates were used to determine the median time to SSE. | Up to approximately 5.5 years |
| Time to SSE in ITT Population | Time to SSE was defined as the time from randomization to the first occurrence of an SSE. A SSE was defined using one of the following: use of external-beam radiotherapy to relieve skeletal symptoms (including initiation of radium-223 to treat symptoms of bone metastases); occurrence of a new symptomatic pathological bone fracture (vertebral or non-vertebral); clinically apparent occurrence of spinal cord compression, or a tumor-related orthopedic surgical intervention. KM estimates were used to determine the median time to SSE. | Up to approximately 5.5 years |
| Objective Response Rate (ORR) Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in PTEN-loss Population | ORR was defined as the percentage of participants who had an objective response (OR) with measurable disease at baseline. An OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria in participants with measurable disease at baseline. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off. | Up to approximately 5.5 years |
| ORR Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in ITT Population | ORR was defined as the percentage of participants who had an OR with measurable disease at baseline. An OR was defined as a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria in participants with measurable disease at baseline. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. Percentage have been rounded off. | Up to approximately 5.5 years |
| Duration of Confirmed Response (DOCR) in PTEN-loss Population | DOCR was defined as the time from the first documented OR (CR or PR) to documented PD as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. DOR was estimated using the KM methodology. | Up to approximately 5.5 years |
| DOCR in ITT Population | DOCR was defined as the time from the first documented OR (CR or PR) to documented PD as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occured first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. DOR was estimated using the KM methodology. | Up to approximately 5.5 years |
| PSA Response Rate in PTEN-loss Population | PSA response rate was defined as the percentage of participants achieving a PSA decline ≥ 50% from baseline. Participants without a post-baseline PSA assessment were considered to be non-responders. Percentages have been rounded off. | Up to approximately 5.5 years |
| PSA Response Rate in ITT Population | PSA response rate was defined as the percentage of participants achieving a PSA decline ≥ 50% from baseline. Participants without a post-baseline PSA assessment were considered to be non-responders. Percentages have been rounded off. | Up to approximately 5.5 years |
| Investigator-assessed rPFS Per PCWG3 Criteria in PTEN-loss Population by Next-generation Sequencing (NGS) | rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator using the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. | Up to approximately 32 months |
| Percentage of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study were also considered as AEs. Percentages have been rounded off. | Up to 28 days after last study drug administration (approximately 6.5 years) |
| Plasma Concentrations of Ipatasertib at Specified Timepoints | Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. | 1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1) (each cycle length= 28 days) |
| Plasma Concentrations of Abiraterone at Specified Timepoints | Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. | Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days) |
| Scottsdale |
| Arizona |
| 85025 |
| United States |
| City of Hope | Duarte | California | 91010 | United States |
| USC Norris Cancer Center | Los Angeles | California | 90033 | United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| Stanford University | Palo Alto | California | 94305 | United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| University of Colorado Hospital - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Lynn Cancer Institute/Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Associates in Oncology/Hematology P.C. | Rockville | Maryland | 20850 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | United States |
| HCA Midwest Division | Kansas City | Missouri | 64132 | United States |
| Urology Cancer Center & GU Research Network | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley | Las Vegas | Nevada | 89169 | United States |
| Hackensack Univ Medical Center | Hackensack | New Jersey | 07601 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Texas Oncology - Gulf Coast | The Woodlands | Texas | 77380 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84132-0001 | United States |
| Macquarie University Hospital | Macquarie University | New South Wales | 2109 | Australia |
| Adelaide Cancer Centre | Kurralta Park | South Australia | 5037 | Australia |
| Monash Medical Centre | EAST Bentleigh | Victoria | VIC 3165 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Eastern Health | Melbourne | Victoria | 3128 | Australia |
| Lkh-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Ordensklinikum Linz Elisabethinen | Linz | 4020 | Austria |
| Landeskrankenhaus Salzburg | Salzburg | 5020 | Austria |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Hospital Luxemburgo | Belo Horizonte | Minas Gerais | 31190-131 | Brazil |
| Liga Norte Riograndense Contra O Câncer | Natal | Rio Grande do Norte | 59040150 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Hamilton Health Sciences - Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Lakeridge Health Oshawa | Oshawa | Ontario | L1G 2B9 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Hopital Sacre-Coeur Research Centre | Montreal | Quebec | H4J 1C5 | Canada |
| CHU de Québec - Université Laval - Hôtel-Dieu de Québec | Québec | G1J 1Z4 | Canada |
| Beijing Friendship Hospital Affiliated of Capital University of Medical Science | Beijing | 100050 | China |
| Jiangsu Cancer Hospital | Nanjing | 210009 | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing | 210029 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| ICIMED Instituto de Investigación en Ciencias Médicas | San José | 1007 | Costa Rica |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| Aarhus Universitetshospital, Urologisk Afd. K | Aarhus N | 8200 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense | 5000 | Denmark |
| ICO Paul Papin | Angers | 49055 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| CHD Vendée | La Roche-sur-Yon | 85025 | France |
| Hopital Claude Huriez | Lille | 59000 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Institut de cancerologie du Gard | Nîmes | 30029 | France |
| Institut Mutualiste Montsouris | Paris | 75674 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| Hopital d'Instruction des Armees de Begin | Saint-Mandé | 94160 | France |
| Hopital Foch | Suresnes | 92151 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Alexandras Hospital | Athens | 115 28 | Greece |
| IASO General Hospital of Athens | Athens | 155 62 | Greece |
| University Hospital of Patras Medical Oncology | Pátrai | 265 04 | Greece |
| Papageorgiou General Hospital | Thessaloniki | 546 29 | Greece |
| Semmelwies University of Medicine | Budapest | 1082 | Hungary |
| Orszagos Onkologiai Intezet | Budapest | 1122 | Hungary |
| Budapesti Uzsoki Utcai Kórház | Budapest | 1145 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | H4032 | Hungary |
| B-A-Z County Hospital | Miskolc | 3526 | Hungary |
| Cork University Hospital | Cork | DUMMY_VALUE | Ireland |
| Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital | Dublin | 24 | Ireland |
| Mater Misericordiae Uni Hospital | Dublin | 7 | Ireland |
| Mater Private Hospital | Dublin | 7 | Ireland |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Belinson Medical Center, Division of Oncology | Petah Tikva | 4941492 | Israel |
| Chaim Sheba medical center, Oncology division | Ramat Gan | 5262000 | Israel |
| Istituto Nazionale Tumori Irccs Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| I.R.S.T Srl IRCCS | Meldola | Emilia-Romagna | 47014 | Italy |
| A.O. Universitaria Policlinico Di Modena | Modena | Emilia-Romagna | 41100 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 00152 | Italy |
| A.O. Istituti Ospitalieri - Cremona | Cremona | Lombardy | 26100 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int) | Milan | Lombardy | 20133 | Italy |
| A.O. San Carlo Borromeo | Milan | Lombardy | 20153 | Italy |
| Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| Ospedale di Trento-Presidio Ospedaliero Santa Chiara | Trento | Trentino-Alto Adige | 38122 | Italy |
| Ospedale Area Aretina Nord | Arezzo | Tuscany | 52100 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Tuscany | 50139 | Italy |
| Nagoya University Hospital | Aichi | 466-8560 | Japan |
| Hirosaki University Hospital | Aomori | 036-8563 | Japan |
| National Cancer Center East | Chiba | 277-8577 | Japan |
| Toho University Sakura Medical Center | Chiba | 285-8741 | Japan |
| Gunma University Hospital | Gunma | 371-8511 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Hokkaido | 003-0804 | Japan |
| Kanazawa University Hospital | Ishikawa | 920-8641 | Japan |
| Yokohama City University Medical Center | Kanagawa | 232-0024 | Japan |
| Kitasato University Hospital | Kanagawa | 252-0375 | Japan |
| Kochi Medical School Hospital | Kochi | 783-8505 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Kyorin University Hospital | Tokyo | 181-8611 | Japan |
| Yamaguchi University Hospital | Yamaguchi | 755-8505 | Japan |
| Hospital Angeles Mocel | Mexico City | Mexico CITY (federal District) | 11850 | Mexico |
| Centro Medico Culiacan SA de CV | Culiacán | Sinaloa | DUMMY_VALUE | Mexico |
| Medical Care & Research | Mérida | Yucatán | 97070 | Mexico |
| Consultorio de Especialidad en Urologia Privado | Durango | 34000 | Mexico |
| Sykehuset Østfold Kalnes | Grålum | 1714 | Norway |
| Akershus universitetssykehus HF | Lørenskog | 1478 | Norway |
| Woj. Wielospec. Centrum Onkologii i Traumatologii | ?ód? | 93-513 | Poland |
| SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego | Opole | 45-060 | Poland |
| Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o. | Warsaw | 04-073 | Poland |
| Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | 53-413 | Poland |
| HUC | Coimbra | 3000-075 | Portugal |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| IPO do Porto | Porto | 4200-072 | Portugal |
| Altai Regional Oncological Center | Barnaul | Altayskiy Kray | 656049 | Russia |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Blokhin Cancer Research Center | Moscow | Moscow Oblast | 115478 | Russia |
| Privolzhsk Regional Medical Center | Nizhny Novgorod | Niznij Novgorod | 603001 | Russia |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Institut Catala d?Oncologia Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Insititut Catala D'Oncologia | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Kaohsiung Medical Uni Chung-Ho Hospital | Kaohsiung City | 807 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| Chang Gung Memorial Hospital-LinKou | Taoyuan | 333 | Taiwan |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp. | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiangmai Hospital | Chiang Mai | 50200 | Thailand |
| Royal Blackburn Hospital | Blackburn | BB2 3HH | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Mount Vernon & Watford Trust Hospital | Northwood | HA6 2RN | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Royal Wolverhampton hospital | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Kotani N, Wilkins JJ, Wade JR, Dang S, Sutaria DS, Yoshida K, Sundrani S, Ding H, Garcia J, Hinton H, Sane R, Chanu P. Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study. Cancer Chemother Pharmacol. 2022 Dec;90(6):511-521. doi: 10.1007/s00280-022-04488-2. Epub 2022 Oct 28. |
| 34246347 | Derived | Sweeney C, Bracarda S, Sternberg CN, Chi KN, Olmos D, Sandhu S, Massard C, Matsubara N, Alekseev B, Parnis F, Atduev V, Buchschacher GL Jr, Gafanov R, Corrales L, Borre M, Stroyakovskiy D, Alves GV, Bournakis E, Puente J, Harle-Yge ML, Gallo J, Chen G, Hanover J, Wongchenko MJ, Garcia J, de Bono JS. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2021 Jul 10;398(10295):131-142. doi: 10.1016/S0140-6736(21)00580-8. |
| FG001 |
| Ipat + Abi |
Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| Safety Evaluable (SE) Population | SE population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis. |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) population included all randomized participants, whether or not the participants received the assigned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pbo + Abi | Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| BG001 | Ipat + Abi | Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Ethnicity | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population | rPFS was defined as time from date of randomization to the first occurrence of documented disease progression (PD), as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm) in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The Kaplan-Meier (KM) estimate was used to determine the median rPFS. | PTEN loss population included all randomized participants with PTEN loss tumors by immunohistochemistry (IHC), regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 32 months |
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| Primary | Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population | rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to RECIST v1.1 criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The KM estimate was used to determine the median rPFS. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 32 months |
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| Secondary | Overall Survival (OS) in PTEN-loss Population | OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 6.5 years |
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| Secondary | OS in ITT Population | OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 6.5 years |
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| Secondary | Time to Pain Progression in PTEN-loss Population | Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point numeric rating scale [NRS], with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to Pain Progression in ITT Population | Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point NRS, with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to Initiation of Cytotoxic Chemotherapy for Prostate Cancer (PC) in PTEN-loss Population | Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to Initiation of Cytotoxic Chemotherapy for PC in ITT Population | Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to Function Deterioration Per European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function (PF) Scale and Role Function (RF) Scale in PTEN-loss Population | Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive&social), 3 symptom scales (fatigue,nausea&vomiting,pain), global health/quality of life (GHS/QoL)&6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea&financial difficulties). PF scale has 5 questions about participants physical functioning&daily activities. RF scale has 2 questions about work/daily activities&hobbies/leisurely activities. PF&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF)&better functioning/support. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to Function Deterioration Per EORTC QLQ-C30 PF Scale and RF Scale in ITT Population | Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive & social), 3 symptom scales (fatigue,nausea&vomiting,pain), GHS/QoL & 6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea & financial difficulties). PF scale has 5 questions about participants physical functioning & daily activities. RF scale has 2 questions about work/daily activities & hobbies/leisurely activities. PF&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF) & better functioning/support. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to Prostate-specific Antigen (PSA) Progression, Per the PCWG3 Criteria in PTEN-loss Population | Time to PSA progression was defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression was defined as a PSA increase that was ≥ 25% and ≥ 2 nanograms per milliliters (ng/mL) above the baseline or the nadir, which was confirmed by a second value ≥ 3 weeks later. KM estimate was used to determine the median time to PSA. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to PSA Progression, Per the PCWG3 Criteria in ITT Population | Time to PSA progression was defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression was defined as a PSA increase that was ≥ 25% and ≥ 2 ng/mL above the baseline or the nadir, which was confirmed by a second value ≥ 3 weeks later. KM estimate was used to determine the median time to PSA. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to First Opioid Use in PTEN-loss Population | Time to first opioid use was defined as the time interval from the date of randomization to the date of an initiation of opioid analgesic use for cancer-related pain, and consumption reported on at least 7 consecutive days. KM estimate was used to determine the median time to first opioid use. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to First Opioid Use in ITT Population | Time to first opioid use was defined as the time interval from the date of randomization to the date of an initiation of opioid analgesic use for cancer-related pain, and consumption reported on at least 7 consecutive days. KM estimate was used to determine the median time to first opioid use. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to Symptomatic Skeletal Event (SSE) in PTEN-loss Population | Time to SSE was defined as the time from randomization to the first occurrence of an SSE. A SSE was defined using one of the following: use of external-beam radiotherapy to relieve skeletal symptoms (including initiation of radium-223 to treat symptoms of bone metastases); occurrence of a new symptomatic pathological bone fracture (vertebral or non-vertebral); clinically apparent occurrence of spinal cord compression, or a tumor-related orthopedic surgical intervention. KM estimates were used to determine the median time to SSE. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Time to SSE in ITT Population | Time to SSE was defined as the time from randomization to the first occurrence of an SSE. A SSE was defined using one of the following: use of external-beam radiotherapy to relieve skeletal symptoms (including initiation of radium-223 to treat symptoms of bone metastases); occurrence of a new symptomatic pathological bone fracture (vertebral or non-vertebral); clinically apparent occurrence of spinal cord compression, or a tumor-related orthopedic surgical intervention. KM estimates were used to determine the median time to SSE. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | Objective Response Rate (ORR) Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in PTEN-loss Population | ORR was defined as the percentage of participants who had an objective response (OR) with measurable disease at baseline. An OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria in participants with measurable disease at baseline. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 5.5 years |
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| Secondary | ORR Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in ITT Population | ORR was defined as the percentage of participants who had an OR with measurable disease at baseline. An OR was defined as a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria in participants with measurable disease at baseline. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. Percentage have been rounded off. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. Overall number analyzed is the number of participants with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 5.5 years |
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| Secondary | Duration of Confirmed Response (DOCR) in PTEN-loss Population | DOCR was defined as the time from the first documented OR (CR or PR) to documented PD as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. DOR was estimated using the KM methodology. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with objective response i.e. responders. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | DOCR in ITT Population | DOCR was defined as the time from the first documented OR (CR or PR) to documented PD as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occured first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. DOR was estimated using the KM methodology. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. Overall number analyzed is the number of participants with objective response i.e. responders. | Posted | Median | 95% Confidence Interval | months | Up to approximately 5.5 years |
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| Secondary | PSA Response Rate in PTEN-loss Population | PSA response rate was defined as the percentage of participants achieving a PSA decline ≥ 50% from baseline. Participants without a post-baseline PSA assessment were considered to be non-responders. Percentages have been rounded off. | PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 5.5 years |
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| Secondary | PSA Response Rate in ITT Population | PSA response rate was defined as the percentage of participants achieving a PSA decline ≥ 50% from baseline. Participants without a post-baseline PSA assessment were considered to be non-responders. Percentages have been rounded off. | ITT population included all randomized participants, whether or not the participants received the assigned treatment. Overall number analyzed included participants with data available for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 5.5 years |
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| Secondary | Investigator-assessed rPFS Per PCWG3 Criteria in PTEN-loss Population by Next-generation Sequencing (NGS) | rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator using the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. | PTEN loss population included all randomized participants with PTEN loss tumors by NGS, regardless of whether or not the participant received the assigned treatment. Number analyzed is the number of participants with data available for analyses. | Posted | Median | 95% Confidence Interval | months | Up to approximately 32 months |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study were also considered as AEs. Percentages have been rounded off. | SE population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis. | Posted | Number | percentage of participants | Up to 28 days after last study drug administration (approximately 6.5 years) |
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| Secondary | Plasma Concentrations of Ipatasertib at Specified Timepoints | Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. | Pharmacokinetic (PK)-evaluable population included all participants who received ipatasertib treatment with evaluable PK samples. Number analyzed per timepoint are unique number of participants out all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1) (each cycle length= 28 days) |
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| Secondary | Plasma Concentrations of Abiraterone at Specified Timepoints | Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. | PK-evaluable population included all participants who received abiraterone treatment with evaluable PK samples. Overall number analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days) |
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Up to approximately 6.5 years
SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
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 | Pbo + Abi | Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. | 358 | 546 | 158 | 546 | 496 | 546 |
| EG001 | Ipat + Abi | Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. | 331 | 551 | 252 | 551 | 541 | 551 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic enteritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bullous erysipelas | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hypobarism | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis chemical | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radiation proctitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Artery dissection | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superior mesenteric artery dissection | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bacterial abdominal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Benign neoplasm of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Laryngeal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Lung adenocarcinoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary fistula | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 23, 2020 | Mar 15, 2023 | SAP_001.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 |
|---|---|
| C583616 | ipatasertib |
| C089740 | abiraterone |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 | Ipat + Abi | Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
|
|
Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
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|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
| Ipat + Abi |
Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
|
|
Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|
|
Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
|
Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
|
|
| Participants |
|
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
| Units | Counts |
|---|---|
| Participants |
|
|