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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000459-41 | EudraCT Number | ||
| CAAA617A12301 | Other Identifier | Novartis |
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The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.
The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period.
Sub-study A dosimetry, PK and ECG sub-study was conducted in a non-randomized cohort (AAA617+BSC/BSoC) of 30 patients at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Aside from additional assessments to collect data for dosimetry, PK, urinary metabolites and ECG, patients in the sub-study were screened for eligibility, treated and followed up similarly to the AAA617+BSC/BSoC (investigational arm) patients in the main study.
Screening and randomization:
During the screening period of up to 28 days before starting randomized treatment, each participant was assessed for PSMA positivity by gallium (68Ga) gozetotide imaging PET/scan per the pre-defined read rules, by the Sponsor's central reader. Only patients with PSMA-positive metastatic PC and meeting all other inclusion/exclusion criteria were randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus BSC/BSoC or BSC/BSoC only. Randomized patients were stratified on the following factors: LDH level (=< or > 260 UI/L), presence of liver metastases (Yes or No), eastern cooperative oncology group (ECOG) score (0-1 or 2) and inclusion of NAAD in the BSC/BSoC (at time of randomization (Yes or No)). Protocol- specified BSC/BSoC for each patient was initiated by the investigating physician prior to patient randomization and maintained throughout the study. On-study changes to BSC/BSoC were allowed and at the discretion of the investigating physician.
Randomized treatment:
"Randomized treatment" in this study refers to AAA617+BSC/BSoC (investigational arm) and BSC/BSoC only (control arm). For the sub-study, "study treatment" refers to AAA617+BSC/BSoC (also referred to as the investigational arm), as no randomization occurred in the sub-study. When discussing aspects of the study which are applicable to both the main and sub-study, the term 'randomized treatment' will be used throughout this document. The term 'study treatment' will be used only when specifically referring to the sub-study.
Patients randomized to the investigational arm began AAA617 dosing within 28 days of randomization. These patients received BSC/BSoC and 7.4 GBq (+/-10%) AAA617 once every 6 weeks (+/- 1 week) for a maximum of 6 cycles.
After the Cycle 4 treatment and prior to Cycle 5 treatment, the Investigator had to determine if:
If the patient met all of the criteria above and agreed to continue with additional treatment of AAA617 the investigator could administer a further 2 cycles. A maximum of 6 cycles of radioligand therapy was allowed. If the patient did not meet any of the criteria or did not agree to additional AAA617 treatment, then no additional doses of AAA617 were administered after Cycle 4. After the last cycle of AAA617, patients continued BSC/BSoC alone, as long as the investigator felt they were clinically benefiting or until they required a treatment regimen not allowed in this study. For both treatment arms, the cycle duration for Cycle 1-6 was 6 weeks and for Cycle 7 and beyond, 12 weeks. From Cycle 7 onwards, all patients from both treatment arms only received BSC/BSoC.
End of treatment:
An End of Treatment (EOT) visit was scheduled approximately 30 days after the last dose of AAA617 or the date of the BSC/BSoC end of treatment decision (whichever occurred later), but before the initiation of subsequent anti-cancer treatment, outside of what was allowed on study. Once a patient discontinued the randomized treatment part of the study for any reason, an EOT visit was scheduled.
Long-term follow-up:
Patients on the active part of the study at the time of the final analysis of OS had an EOT visit at the next planned visit after implementation of V5.0/5.1 of the protocol and moved into long-term follow-up, unless they specifically withdrew consent from long-term follow-up of the study.
Patients who consented to be followed for long-term status updates, entered the long-term follow-up period after the EOT visit. The long-term follow-up period included the collection of rPFS (if the patient discontinued for reasons other than radiographic progression), OS, information about new treatments along with the patient's response to these treatments, AE assessment, and results of hematology and chemistry testing. During the follow-up, patients were contacted every 3 months (+/-1 month) via phone, email, or letter until a long-term follow-up study became available, until death or until withdrawal of consent, whichever occurred first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) | Experimental | Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used |
|
| Best supportive/best standard of care (BS/BSOC) alone | Other | Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-PSMA-617 | Drug | Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. After 4 cycles, patients were assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments were met the patient might received an additional 2 cycles of 177Lu-PSMA-617. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-free Survival (rPFS) | Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of randomization to the date of radiographic disease progression based on the central review assessment per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause. Patients who were alive without radiographic progression at the analysis data cut-off were censored for rPFS at the time of their last evaluable radiographic assessment. Date of censoring for rPFS: 1) The censoring date was the date when the last evaluable radiographic assessment (CT/MRI/bone scan) determined a lack of progression; 2) If there were no evaluable assessments, censoring occurred at the date of randomization; 3) Patients who had 2 or more consecutive missed tumor assessments immediately prior to PD or death were censored at the date of the last evaluable tumor assessment prior to those missing tumor assessments. | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Overall Survival (OS) | Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date. Final OS was analyzed at the time of Primary analysis (Primary Analysis cut-off date = 27-Jan-2021) and an updated descriptive analysis of OS was re-run at the time of final analysis (Final Analysis cut-off date 14-Dec-2023). | From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE) | In the Main Study, "randomized treatment" refers to the investigational arm (AAA617+BSC/BSoC) and the control arm (BSC/BSoC). In the sub-study, "study treatment" refers to the investigational arm (AAA617+BSC/BSoC) without randomization:
The distribution of randomized/study treatment-emergent adverse events (TEAEs) was done via the analysis of frequencies for TEAEs and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters. |
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Inclusion Criteria:
Patients must have the ability to understand and sign an approved informed consent form (ICF).
Patients must have the ability to understand and comply with all protocol requirements.
Patients must be >= 18 years of age.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Patients must have a life expectancy >6 months.
Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader.
Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).
Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if: a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.).
Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
Patients must have >= 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained =< 28 days prior to beginning study therapy.
Patients must have recovered to =< Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
Patients must have adequate organ function:
a. Bone marrow reserve:
Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) [Inclusion #16 has been removed]
17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial.
18. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.
19. The best standard of care/ best supportive care options planned for this patient:
Exclusion Criteria:
Prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of Arizona Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31595044 | Result | Iravani A, Violet J, Azad A, Hofman MS. Lutetium-177 prostate-specific membrane antigen (PSMA) theranostics: practical nuances and intricacies. Prostate Cancer Prostatic Dis. 2020 Mar;23(1):38-52. doi: 10.1038/s41391-019-0174-x. Epub 2019 Oct 8. | |
| 38534939 | Result | Chi KN, Yip SM, Bauman G, Probst S, Emmenegger U, Kollmannsberger CK, Martineau P, Niazi T, Pouliot F, Rendon R, Hotte SJ, Laidley DT, Saad F. 177Lu-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer: A Review of the Evidence and Implications for Canadian Clinical Practice. Curr Oncol. 2024 Mar 7;31(3):1400-1415. doi: 10.3390/curroncol31030106. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The study was conducted in 86 sites across 9 countries. Belgium (3); Canada (7); Denmark (3); France (6); Netherlands (4); Sweden (5); UK (9); US (45); Germany (4, for the sub-study only).
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used |
| FG001 |
| 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 | Sep 14, 2022 | Dec 13, 2024 |
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Participants in the Main Study were randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus BSC/BSoC or BSC/BSoC only. The sub-study was conducted in a non-randomized cohort (AAA617+ BSC/BSoC)
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| Best supportive/best standard of care | Other | Best supportive/best standard of care as defined by the local investigator |
|
| From randomization till 30 days safety follow-up, assessed up to 66 months (Final Analysis cut-off date = 14-Dec-2023) |
| Overall Response Rate (ORR) | Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with evaluable disease at baseline per central review assessment. | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Disease Control Rate (DCR) | Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 per central review assessment. | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Duration of Response (DOR) | Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as per central review assessment. | From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Time to First Symptomatic Skeletal Event (SSE) | Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of randomization to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. SSE data for this endpoint were collected up through EOT visit. The censoring date was date of the last study visit (on or before the EOT visit). | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the time (in months) from the date of randomization to the date of first evidence of radiographic, clinical or PSA progression or death due to any cause, whichever occurred first. | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level | Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled). | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response | PSA response was defined as the proportion of patients who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later. | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Prostate-specific Antigen 80 (PSA80) Response | PSA80 response was defined as the proportion of participants who had a >= 80% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later. | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Duration of PSA Response | Duration of PSA response was defined as the duration between the date of first document PSA response (i.e. >= 50% decrease in PSA from Baseline) and the earliest date of PSA progression, where date of PSA progression was defined as: 1) Where a decline from baseline was documented, date that a >= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose of randomized treatment were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a >= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose of randomized treatment (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines. | From date of first documented PSA response till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level | Best percentage change from baseline in alkaline phosphatase (ALP) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled). | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level | Best percentage change from baseline in lactate dehydrogenase (LDH) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled). | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Time to Worsening in BPI-SF Pain Intensity Scale | Time to worsening in BPI-SF pain intensity scale was defined as the time from randomization to the first occurring of an increase of worsening threshold (>=30% of baseline or >=2-point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death. | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Time to Improvement After Worsening in BPI-SF Pain Intensity Scale | Time to improvement after worsening in BPI-SF pain intensity scale was defined as the time from worsening of Pain Intensity score to a Pain Intensity score <= baseline. | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Time to Worsening in BPI-SF Pain Interference Scale | Time to worsening in BPI-SF pain interference scale was defined as the time from randomization to the first occurring of 1) an increase of worsening threshold (>=30% of baseline or >=2-point increase) at any time up through EOT visit compared to baseline, 2) clinical disease progression, or 3) death. | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Time to Improvement After Worsening in BPI-SF Pain Interference Scale | Time to improvement after worsening in BPI-SF pain interference scale was defined as the time from worsening of Pain Interference score to a Pain Interference score <= baseline. | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain) | Time to worsening in BPI-SF worst pain intensity scale (time to disease related pain) was defined as the time from randomization to the first occurring of worsening exceeding the threshold threshold (>=30% of baseline or >=2 point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death. | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Intensity Scale | The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Intensity items consist of an 11-response rating scale scored from 0 ("No Pain") to 10 ("Pain As Bad As You Can Imagine"). BPI-SF Pain intensity is the mean of non-missing items of the 4 individual scales, if there are 3 or more items not missing; otherwise this scale is set to missing. | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
| Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale | The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Interference items consist of scores from 0 ("Does Not Interfere") to 10 ("Completely Interferes"). BPI-SF Interference scale is the mean of non-missing items of the 7 items on pain interference, if there are 4 or more items not missing; otherwise this scale is set to missing. | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
| Time to Worsening in FACT-P Total Score | Time to worsening was defined as the time from randomization to the first occurring of a >=10 point decrease in FACT-P total score compared to baseline, clinical disease progression, or death. | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score | The FACT-P total score (range 0-156) consist of five subscales (Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24)) and a functional well-being and prostate cancer subscale (range 0-48). Higher scores indicate higher degree of functioning and better quality of life. | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
| Time to Worsening in EQ-5D-5L Utility Score | Time to worsening for utility score was defined as time from randomization to the first occurrence of worsening in utility score relative to baseline (no change or any decrease), clinical disease progression, or death. | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score | The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales. The weights were based on value sets which were country-specific for the U.K. Utility scores ranges from the lowest possible score for a living patient of -0.594 (when all responses are '5') to 1 (when all responses are '1').If a patient died, he was assigned a score of 0 on the date of death. | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
| Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS | The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The higher the EQ-VAS score, the better the QoL. | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
| Number of Participants Hospitalized as In-patient | The number of hospitalizations (yes/no) (admitted as in-patient) was collected as part of the hospital admission for health economic evaluations. | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Duration of Time in Hospital Following 177Lu-PSMA-617 Administration | The duration of time in hospital following 177Lu-PSMA-617 administration (hours) was the time span of patient discharged as captured on the 177Lu-PSMA-617 administration Case Report Form (CRF). | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Concomitant Drug Use for Health Economics Analysis | The list of concomitant drugs as captured on the concomitant medication/therapy CRF page to include in each category was pre-specified and flagged prior to the pre planned analyses. (1) Bisphosphonates (including but not limited to zoledronic acid, alendronic acid, etc.), denosumab, and other bone targeted therapies), (2) Corticosteroids for systemic use (3), Antifungals for systemic use (i.e. ketoconazole), (4) ESA (erythropoietin stimulating agents, i.e. epoetin alfa), (5) Granulocyte macrophage colony-stimulating factor (GM-CSF), (6) Novel androgen axis drugs (NAADs; i.e. enzalutamide, abiraterone, apalutamide), (7) Antiemetics and (8) Opioid analgesics use for cancer-related pain. | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Therapeutic Interventions for Health Economics Analysis | The list of therapeutic interventions was pre-specified and flagged prior to the pre planned analyses as captured on: 1) the concurrent radiotherapy CRF page to include local external beam radiotherapy (inclusive of palliative external radiation), 2) on the concomitant medication/therapy CRF page to include blood transfusion (full blood or derivates). | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
| Tucson |
| Arizona |
| 85719-1454 |
| United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| University of California Los Angeles, Nuclear Medicine | Los Angeles | California | 90095 | United States |
| Stanford Cancer Institute | Palo Alto | California | 94305 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| Washington DC VA Medical Center, Nuclear Medicine Service | Washington D.C. | District of Columbia | 20422 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Iowa City VA Medical Center | Iowa City | Iowa | 52246 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Tulane Medical Center, Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Chesapeake Urology Associates (CUA) P.A. | Towson | Maryland | 21204 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215-5450 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan Hospitals | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Saint Louis University Hospital | St Louis | Missouri | 63104 | United States |
| VA St. Louis Health Care System - John Cochran | St Louis | Missouri | 63106 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1093 | United States |
| XCancer Omaha / Urology Cancer Center | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada - Twain Office | Las Vegas | Nevada | 89169 | United States |
| Regional Cancer Care Associates, Central Jersey Division | East Brunswick | New Jersey | 08816 | United States |
| New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| New York Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Duke University Medical Center, Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | United States |
| Oregon Health and Science University, Nuclear Medicine | Portland | Oregon | 97239-3098 | United States |
| Pennsylvania Cancer Specialists & Research Institute | Gettysburg | Pennsylvania | 17325 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| VA North Texas Health Care System, Nuclear Medicine Service | Dallas | Texas | 75216 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Excel Diagnostics & Nuclear Oncology Center | Houston | Texas | 77042 | United States |
| Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22903 | United States |
| Swedish Cancer Institute Research | Seattle | Washington | 98104 | United States |
| Jules Bordet Institute | Brussels | Belgium |
| Saint Luc University Hospital | Brussels | Belgium |
| University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine | Leuven | Belgium |
| BC Cancer - Vancouver | Vancouver | British Columbia | V5Z 4E6 | Canada |
| London Health Sciences Centre, Division of Nuclear Medicine | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital, Cancer Center | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Research Institute, Odette Cancer Center | Toronto | Ontario | M4N 3M5 | Canada |
| CHUM - University Hospital of Montreal | Montreal | Quebec | H2X 3E4 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CHU of Quebec - Laval University | Québec | G1R 2J6 | Canada |
| Aalborg University Hospital, Oncology Department | Aalborg | Denmark |
| Aarhus University Hospital, Department of Oncology | Aarhus | Denmark |
| Rigshospitalet - University Hospital Copenhagen, Department of Oncology | Copenhagen | Denmark |
| Bergonie Institute | Bordeaux | France |
| Center Jean Perrin | Clermont-Ferrand | France |
| Leon Berard Center | Lyon | France |
| Saint-Louis Hospital | Paris | France |
| Tenon Hospital | Paris | France |
| Institute Claudius Regaud, Toulouse Cancer Research Center | Toulouse | France |
| Gustave Roussy Oncology Institute | Villejuif | France |
| University Hospital Essen, Clinic for Nuclear Medicine | Essen | Germany |
| Hospital rechts der Isar, Department of Nuclear Medicine | Munich | Germany |
| University Hospital Muenster, Department of Nuclear Medicine | Münster | Germany |
| Rostock University Medical Center, Clinic and Polyclinic for Nuclear Medicine | Rostock | Germany |
| The Netherlands Cancer Institute | Amsterdam | Netherlands |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| Radboud University Medical Center (Radboudumc) | Nijmegen | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| VA Caribbean Healthcare System | San Juan | 00921 | Puerto Rico |
| Sahlgrenska University Hospital, Department of Oncology | Gothenburg | Sweden |
| Skane University Hospital - Barngatan, Clinical Trials Unit | Lund | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| Norrlands University Hospital, Cancer Center | Umeå | Sweden |
| Uppsala University Hospital, Department of Oncology | Uppsala | Sweden |
| Bristol Hematology & Oncology Center | Bristol | United Kingdom |
| Beatson West of Scotland Cancer Center | Glasgow | United Kingdom |
| Royal Surrey County Hospital | Guildford | United Kingdom |
| Guy's Hospital | London | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| St Bartholomew's Hospital | London | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | United Kingdom |
| Institute of Cancer Research | Sutton | United Kingdom |
| 37269841 | Result | Fizazi K, Herrmann K, Krause BJ, Rahbar K, Chi KN, Morris MJ, Sartor O, Tagawa ST, Kendi AT, Vogelzang N, Calais J, Nagarajah J, Wei XX, Koshkin VS, Beauregard JM, Chang B, Ghouse R, DeSilvio M, Messmann RA, de Bono J. Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):597-610. doi: 10.1016/S1470-2045(23)00158-4. |
| 38050121 | Result | Herrmann K, Rahbar K, Eiber M, Sparks R, Baca N, Krause BJ, Lassmann M, Jentzen W, Tang J, Chicco D, Klein P, Blumenstein L, Basque JR, Kurth J. Renal and Multiorgan Safety of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer in the VISION Dosimetry Substudy. J Nucl Med. 2024 Jan 2;65(1):71-78. doi: 10.2967/jnumed.123.265448. |
| 37230533 | Result | Kuo PH, Yoo DC, Avery R, Seltzer M, Calais J, Nagarajah J, Weber WA, Fendler WP, Hofman MS, Krause BJ, Brackman M, Kpamegan E, Ghebremariam S, Benson T, Catafau AM, Kendi AT. A VISION Substudy of Reader Agreement on 68Ga-PSMA-11 PET/CT Scan Interpretation to Determine Patient Eligibility for 177Lu-PSMA-617 Radioligand Therapy. J Nucl Med. 2023 Aug;64(8):1259-1265. doi: 10.2967/jnumed.122.265077. Epub 2023 May 25. |
| 34161051 | Result | Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23. |
| 39242323 | Result | Armstrong AJ, Sartor O, de Bono J, Chi K, Fizazi K, Krause BJ, Herrmann K, Rahbar K, Tagawa ST, Saad F, Beer TM, Wu J, Mirante O, Morris MJ. Association of Declining Prostate-specific Antigen Levels with Clinical Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer Receiving [177Lu]Lu-PSMA-617 in the Phase 3 VISION Trial. Eur Urol. 2024 Dec;86(6):552-562. doi: 10.1016/j.eururo.2024.08.021. Epub 2024 Sep 5. |
| 38185538 | Result | Chi KN, Armstrong AJ, Krause BJ, Herrmann K, Rahbar K, de Bono JS, Adra N, Garje R, Michalski JM, Kempel MM, Fizazi K, Morris MJ, Sartor O, Brackman M, DeSilvio M, Wilke C, Holder G, Tagawa ST. Safety Analyses of the Phase 3 VISION Trial of [177Lu]Lu-PSMA-617 in Patients with Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2024 Apr;85(4):382-391. doi: 10.1016/j.eururo.2023.12.004. Epub 2024 Jan 6. |
| 39430616 | Result | Herrmann K, Gafita A, de Bono JS, Sartor O, Chi KN, Krause BJ, Rahbar K, Tagawa ST, Czernin J, El-Haddad G, Wong CC, Zhang Z, Wilke C, Mirante O, Morris MJ, Fizazi K. Multivariable models of outcomes with [177Lu]Lu-PSMA-617: analysis of the phase 3 VISION trial. EClinicalMedicine. 2024 Oct 4;77:102862. doi: 10.1016/j.eclinm.2024.102862. eCollection 2024 Nov. |
| 39162634 | Result | Kuo PH, Morris MJ, Hesterman J, Kendi AT, Rahbar K, Wei XX, Fang B, Adra N, Garje R, Michalski JM, Chi K, de Bono J, Fizazi K, Krause B, Sartor O, Tagawa ST, Ghebremariam S, Brackman M, Wong CC, Catafau AM, Benson T, Armstrong AJ, Herrmann K. Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in Metastatic Castration-resistant Prostate Cancer Following 177Lu-PSMA-617 (VISION Trial). Radiology. 2024 Aug;312(2):e233460. doi: 10.1148/radiol.233460. |
| 39031642 | Result | Morris MJ, de Bono J, Nagarajah J, Sartor O, Wei XX, Nordquist LT, Koshkin VS, Chi KN, Krause BJ, Herrmann K, Rahbar K, Vickers A, Mirante O, Ghouse R, Fizazi K, Tagawa ST. Correlation analyses of radiographic progression-free survival with clinical and health-related quality of life outcomes in metastatic castration-resistant prostate cancer: Analysis of the phase 3 VISION trial. Cancer. 2024 Oct 15;130(20):3426-3435. doi: 10.1002/cncr.35438. Epub 2024 Jun 21. |
| 33189510 | Derived | Sundlov A, Sjogreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12. |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone |
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
| FG002 | Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study |
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| FAS Safety Analysis Set | The subset of patients in the Full Analysis Set (FAS) who received at least one dose of randomized treatment. |
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| Progression-Free Survival (PFS) Full Analysis Set (PFS-FAS) | All patients randomized on or after 05-Mar-2019. Patients were included in the treatment arm to which they were randomized regardless of actual treatment received. |
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| Response Evaluable Analysis Set | The subset of patients in the PFS-FAS with evaluable disease by RECIST at baseline. Patients were included in the treatment arm to which they were randomized. |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used |
| BG001 | Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
| BG002 | Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race 'Other' included Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native and more than one race reported. | Number | 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 | Radiographic Progression-free Survival (rPFS) | Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of randomization to the date of radiographic disease progression based on the central review assessment per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause. Patients who were alive without radiographic progression at the analysis data cut-off were censored for rPFS at the time of their last evaluable radiographic assessment. Date of censoring for rPFS: 1) The censoring date was the date when the last evaluable radiographic assessment (CT/MRI/bone scan) determined a lack of progression; 2) If there were no evaluable assessments, censoring occurred at the date of randomization; 3) Patients who had 2 or more consecutive missed tumor assessments immediately prior to PD or death were censored at the date of the last evaluable tumor assessment prior to those missing tumor assessments. | PFS Full Analysis Set (PFS-FAS) | Posted | Median | 99.2% Confidence Interval | Months | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Primary | Overall Survival (OS) | Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date. Final OS was analyzed at the time of Primary analysis (Primary Analysis cut-off date = 27-Jan-2021) and an updated descriptive analysis of OS was re-run at the time of final analysis (Final Analysis cut-off date 14-Dec-2023). | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023) |
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| Secondary | Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE) | In the Main Study, "randomized treatment" refers to the investigational arm (AAA617+BSC/BSoC) and the control arm (BSC/BSoC). In the sub-study, "study treatment" refers to the investigational arm (AAA617+BSC/BSoC) without randomization:
The distribution of randomized/study treatment-emergent adverse events (TEAEs) was done via the analysis of frequencies for TEAEs and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters. | FAS Safety Analysis Set. A patient with multiple grades for an AE is only counted under the maximum grade. Drug-related is related to any study drug (177Lu-PSMA-617 or BSC/BSoC). Study treatment refers to 177Lu-PSMA-617+BSC/BSoC. | Posted | Number | Participants | From randomization till 30 days safety follow-up, assessed up to 66 months (Final Analysis cut-off date = 14-Dec-2023) |
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| Secondary | Overall Response Rate (ORR) | Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with evaluable disease at baseline per central review assessment. | Response Evaluable Analysis Set | Posted | Count of Participants | Participants | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Disease Control Rate (DCR) | Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 per central review assessment. | Response Evaluable Analysis Set | Posted | Count of Participants | Participants | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Duration of Response (DOR) | Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as per central review assessment. | PFS Full Analysis Set (PFS-FAS). Only participants for whom BOR was CR or PR and evaluable Duration of Response events (Progression or Death) included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Time to First Symptomatic Skeletal Event (SSE) | Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of randomization to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. SSE data for this endpoint were collected up through EOT visit. The censoring date was date of the last study visit (on or before the EOT visit). | PFS Full Analysis Set (PFS-FAS) | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the time (in months) from the date of randomization to the date of first evidence of radiographic, clinical or PSA progression or death due to any cause, whichever occurred first. | PFS Full Analysis Set (PFS-FAS) | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level | Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled). | PFS Full Analysis Set (PFS-FAS). Only participants with evaluable post-baseline and baseline samples were included in the analysis. | Posted | Mean | Standard Deviation | Percentage change | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response | PSA response was defined as the proportion of patients who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later. | PFS Full Analysis Set (PFS-FAS) | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Prostate-specific Antigen 80 (PSA80) Response | PSA80 response was defined as the proportion of participants who had a >= 80% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later. | PFS Full Analysis Set (PFS-FAS) | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Duration of PSA Response | Duration of PSA response was defined as the duration between the date of first document PSA response (i.e. >= 50% decrease in PSA from Baseline) and the earliest date of PSA progression, where date of PSA progression was defined as: 1) Where a decline from baseline was documented, date that a >= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose of randomized treatment were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a >= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose of randomized treatment (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines. | PFS Full Analysis Set (PFS-FAS). Only participants with PSA progression were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From date of first documented PSA response till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level | Best percentage change from baseline in alkaline phosphatase (ALP) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled). | PFS Full Analysis Set (PFS-FAS). Only participants with evaluable post-baseline and baseline samples were included in the analysis. | Posted | Mean | Standard Deviation | Percentage change | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level | Best percentage change from baseline in lactate dehydrogenase (LDH) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled). | PFS Full Analysis Set (PFS-FAS). Only participants with evaluable post-baseline and baseline samples were included in the analysis. | Posted | Mean | Standard Deviation | Percentage change | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Time to Worsening in BPI-SF Pain Intensity Scale | Time to worsening in BPI-SF pain intensity scale was defined as the time from randomization to the first occurring of an increase of worsening threshold (>=30% of baseline or >=2-point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death. | PFS-Full analysis set. Only participants with evaluable events were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Time to Improvement After Worsening in BPI-SF Pain Intensity Scale | Time to improvement after worsening in BPI-SF pain intensity scale was defined as the time from worsening of Pain Intensity score to a Pain Intensity score <= baseline. | PFS-Full analysis set. Only participants with evaluable events were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Time to Worsening in BPI-SF Pain Interference Scale | Time to worsening in BPI-SF pain interference scale was defined as the time from randomization to the first occurring of 1) an increase of worsening threshold (>=30% of baseline or >=2-point increase) at any time up through EOT visit compared to baseline, 2) clinical disease progression, or 3) death. | PFS-Full analysis set. Only participants with evaluable events were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Time to Improvement After Worsening in BPI-SF Pain Interference Scale | Time to improvement after worsening in BPI-SF pain interference scale was defined as the time from worsening of Pain Interference score to a Pain Interference score <= baseline. | PFS-Full analysis set. Only participants with evaluable events were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain) | Time to worsening in BPI-SF worst pain intensity scale (time to disease related pain) was defined as the time from randomization to the first occurring of worsening exceeding the threshold threshold (>=30% of baseline or >=2 point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death. | PFS-Full analysis set. Only participants with evaluable events were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Intensity Scale | The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Intensity items consist of an 11-response rating scale scored from 0 ("No Pain") to 10 ("Pain As Bad As You Can Imagine"). BPI-SF Pain intensity is the mean of non-missing items of the 4 individual scales, if there are 3 or more items not missing; otherwise this scale is set to missing. | PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
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| Secondary | Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale | The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Interference items consist of scores from 0 ("Does Not Interfere") to 10 ("Completely Interferes"). BPI-SF Interference scale is the mean of non-missing items of the 7 items on pain interference, if there are 4 or more items not missing; otherwise this scale is set to missing. | PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
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| Secondary | Time to Worsening in FACT-P Total Score | Time to worsening was defined as the time from randomization to the first occurring of a >=10 point decrease in FACT-P total score compared to baseline, clinical disease progression, or death. | PFS-Full analysis set | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
|
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| Secondary | Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score | The FACT-P total score (range 0-156) consist of five subscales (Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24)) and a functional well-being and prostate cancer subscale (range 0-48). Higher scores indicate higher degree of functioning and better quality of life. | PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
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| Secondary | Time to Worsening in EQ-5D-5L Utility Score | Time to worsening for utility score was defined as time from randomization to the first occurrence of worsening in utility score relative to baseline (no change or any decrease), clinical disease progression, or death. | PFS-Full analysis set | Posted | Median | 95% Confidence Interval | Months | From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
|
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| Secondary | Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score | The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales. The weights were based on value sets which were country-specific for the U.K. Utility scores ranges from the lowest possible score for a living patient of -0.594 (when all responses are '5') to 1 (when all responses are '1').If a patient died, he was assigned a score of 0 on the date of death. | PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
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| Secondary | Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS | The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The higher the EQ-VAS score, the better the QoL. | PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks) |
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| Secondary | Number of Participants Hospitalized as In-patient | The number of hospitalizations (yes/no) (admitted as in-patient) was collected as part of the hospital admission for health economic evaluations. | PFS Full Analysis Set (PFS-FAS) | Posted | Count of Participants | Participants | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Duration of Time in Hospital Following 177Lu-PSMA-617 Administration | The duration of time in hospital following 177Lu-PSMA-617 administration (hours) was the time span of patient discharged as captured on the 177Lu-PSMA-617 administration Case Report Form (CRF). | PFS Full Analysis Set (PFS-FAS) | Posted | Mean | Standard Deviation | Hours | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Concomitant Drug Use for Health Economics Analysis | The list of concomitant drugs as captured on the concomitant medication/therapy CRF page to include in each category was pre-specified and flagged prior to the pre planned analyses. (1) Bisphosphonates (including but not limited to zoledronic acid, alendronic acid, etc.), denosumab, and other bone targeted therapies), (2) Corticosteroids for systemic use (3), Antifungals for systemic use (i.e. ketoconazole), (4) ESA (erythropoietin stimulating agents, i.e. epoetin alfa), (5) Granulocyte macrophage colony-stimulating factor (GM-CSF), (6) Novel androgen axis drugs (NAADs; i.e. enzalutamide, abiraterone, apalutamide), (7) Antiemetics and (8) Opioid analgesics use for cancer-related pain. | PFS Full Analysis Set (PFS-FAS) | Posted | Count of Participants | Participants | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Secondary | Therapeutic Interventions for Health Economics Analysis | The list of therapeutic interventions was pre-specified and flagged prior to the pre planned analyses as captured on: 1) the concurrent radiotherapy CRF page to include local external beam radiotherapy (inclusive of palliative external radiation), 2) on the concomitant medication/therapy CRF page to include blood transfusion (full blood or derivates). | PFS Full Analysis Set (PFS-FAS) | Posted | Count of Participants | Participants | From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021) |
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| Post-Hoc | All Collected Deaths | Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from first dose of study medication to 30 days after last dose of study medication (on-treatment), up to approximately 43 months. Deaths were collected in the post treatment survival follow up from 31 days after last dose of study medication until the end of the study, up to approximately 66 months. These are not considered AEs | Full Analysis Set (FAS) and the participants included in the sub-study. | Posted | Count of Participants | Participants | Pre-treatment deaths: Up to 28 days prior to treatment. On-treatment deaths: Up to approximately 43 months. Post-treatment deaths: Up to approximately 66 months |
|
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 43 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 66 months.
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
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 | Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | Main Study: 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Events up to 30 days post-treatment | 68 | 551 | 195 | 529 | 502 | 529 |
| EG001 | Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | Main Study: Best supportive/best standard of care (BS/BSOC) alone - Events up to 30 days post-treatment | 19 | 280 | 58 | 205 | 151 | 205 |
| EG002 | Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study | 5 | 30 | 9 | 30 | 28 | 30 |
| EG003 | Main Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care(BS/BSOC) | Main Study (Post-Treatment Survival Follow-Up): 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Deaths in the post-treatment survival follow-up were not considered adverse events. | 389 | 461 | 0 | 0 | 0 | 0 |
| EG004 | Main Study (Post-Tx Survival FU): Best Supportive/Best Standard of Care (BS/BSOC) Alone | Main Study (Post-Treatment Survival Follow-Up): Best supportive/best standard of care (BS/BSOC) alone - Deaths in the post-treatment survival follow-up were not considered adverse events. | 182 | 186 | 0 | 0 | 0 | 0 |
| EG005 | Sub Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | Sub Study (Post-Treatment Survival Follow-Up): 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Deaths in the post-treatment survival follow-up were not considered adverse events. | 16 | 25 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vascular malformation | Congenital, familial and genetic disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diplegia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoglossal nerve paralysis | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pachymeningitis | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Spinal cord disorder | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Malignant urinary tract obstruction | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Euthanasia | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
| |
| Neck dissection | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
| |
| Pain management | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2021 | Apr 12, 2022 | 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 |
|---|---|
| C000610110 | Pluvicto |
Not provided
Not provided
Not provided
| ≥ 65-84 years |
|
| ≥ 85 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Missing |
|
|
|
|
| OG001 | Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
| OG002 | Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study |
|
|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone |
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG001 |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone |
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
|
|
| OG001 |
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone |
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 | Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
|
|
|
|
|
|
|
|
| Participants |
|
|
| Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) |
non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study |
|
|