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| ID | Type | Description | Link |
|---|---|---|---|
| 20210249 | Other Identifier | Amgen |
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Sponsor strategic decision
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This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified. |
|
| Dose Expansion | Experimental | An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 340 | Drug | AMG 340 is a bispecific antibody targeting prostate-specific membrane antigen (PSMA) on tumor cells and CD3 on T-cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. A treatment-related AE (TRAE) was defined as any TEAE flagged as possibly caused by AMG 340. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were any untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. | From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months |
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | A DLT was defined as a TEAE that was not unequivocally due to the participant's underlying malignancy or other extraneous cause, and appeared within 21 days from the first dose of AMG 340. AEs considered DLTs were:
| Up to approximately Day 21 |
| Median Concentration of AMG 340 | Blood samples for pharmacokinetics (PK) analysis were collected at specific time points. PK parameters were estimated using standard non-compartmental approaches. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | OR was defined as a partial response (PR) or complete response (CR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed PR/CR or did not have any follow-up tumor assessments were regarded as non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94158 | United States | ||
| Sarah Cannon Research Institute at HealthONE |
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The study was designed to consist of two parts: a monotherapy dose escalation (Part A) and a monotherapy dose expansion (Part B). For strategic reasons, the study was terminated before enrollment into Part B could begin. Dose A is the lowest dose, Dose I is the highest dose.
Participants with progressive metastatic castrate-resistant prostate carcinoma (mCRPC) participated in the study from April 2021 to June 2024, and were enrolled across 6 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: AMG 340 Dose A | Participants with progressive mCRPC received AMG 340 Dose A administered as an intravenous (IV) infusion every 3 week (Q3W) in 21-day cycles. |
| FG001 | Cohort 2: AMG 340 Dose B | Participants with progressive mCRPC received AMG 340 Dose B administered as an IV infusion Q3W in 21-day cycles. |
| FG002 | Cohort 3: AMG 340 Dose C | Participants with progressive mCRPC received AMG 340 Dose C administered as an IV infusion Q3W every 21-day cycle. |
| FG003 | Cohort 4: AMG 340 Dose D | Participants with progressive mCRPC received AMG 340 Dose D administered as an IV infusion Q3W in 21-day cycles. |
| FG004 | Cohort 5: AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 Dose E administered as an IV infusion Q3W in 21-day cycles. |
| FG005 | Cohort 6a: AMG 340 Priming Dose (PmD) (High) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 (high) PmD on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| FG006 | Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| FG007 | Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| FG008 | Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| FG009 | Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| FG010 | Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set (SAS): All participants who received at least 1 dose of AMG 340.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Dose A | Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W). |
| BG001 | Cohort 2: Dose B | Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. A treatment-related AE (TRAE) was defined as any TEAE flagged as possibly caused by AMG 340. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were any untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. | SAS: All participants who received at least 1 dose of AMG 340. | Posted | Count of Participants | Participants | From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months |
|
Death: From enrollment through end of study; median (min, max) time on study was 7.4 (0.5, 28.2) months. TEAE: From enrollment up to and including a maximum of 90 days after last dose of AMG 340; median (min, max) duration was 4.3 (0.5, 27.1) months.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Dose A | Participants with progressive mCRPC received Dose A of AMG 340 administered as an IV infusion Q3W. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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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 | Dec 7, 2022 | Apr 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2024 | Apr 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Cohorts 1-5: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 8, and 10; Cohorts 6-10: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 5 (pre-dose to 6 hours post-dose), 6, 7, 8 (pre-dose to 6 hours post-dose), 9, 10 |
| Up to approximately 24 months |
| Overall Survival (OS) | OS was defined as the time from the date of study Day 1 until death due to any cause. | Up to approximately 24 months |
| Prostate Specific Antigen (PSA) Progression Free Survival (PFS) | PSA PFS was defined as the interval from study day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement. If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or unknown, PSA PFS was censored at study day 1. | Up to approximately 24 months |
| Radiographic PFS (rPFS) | rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. If a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1. | Up to approximately 24 months |
| Percentage of Participants With rPFS at 6 Months | rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. If a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1. | 6 months |
| Percentage of Participants With a 30% Reduction From Baseline in PSA (PSA30) | PSA 30 was defined as a ≥ 30% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | Up to approximately 24 months |
| Percentage of Participants With a 50% Reduction From Baseline in PSA (PSA50) | PSA 50 was defined as a ≥ 50% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | Up to approximately 24 months |
| Percentage of Participants With a 70% Reduction From Baseline in PSA (PSA70) | PSA 70 was defined as a ≥ 70% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | Up to approximately 24 months |
| Percentage of Participants With a 90% Reduction From Baseline in PSA (PSA90) | PSA 90 was defined as a ≥ 90% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | Up to approximately 24 months |
| Duration of Response (DOR) Per RECIST 1.1 | DOR was defined as the time from the date of an initial objective response per RECIST 1.1, which was subsequently confirmed, until soft-tissue progression per RECIST 1.1 or death, whichever occurred first in the absence of subsequent anti-cancer therapy. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan prior to subsequent anti-cancer therapy. This endpoint only applied to participants with an objective response (CR or PR) per RECIST 1.1. No participants achieved CR or PR, therefore, no participants could be analyzed for this outcome measure. | Up to approximately 24 months |
| Number of Participants With Symptomatic Skeletal Events (SSE) | SSE was defined as time from study day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of AMG 340 or end of safety follow-up date, whichever was later. | Up to approximately 24 months |
| Denver |
| Colorado |
| 80218 |
| United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10128 | United States |
| Thomas Jefferson University - Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | 19107 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Decision by sponsor |
|
| BG002 | Cohort 3: Dose C | Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W. |
| BG003 | Cohort 4: Dose D | Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W. |
| BG004 | Cohort 5: Dose E | Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W. |
| BG005 | Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| BG006 | Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| BG007 | Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| BG008 | Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| BG009 | Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| BG010 | Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| BG011 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Cohort 1: Dose A | Participants with progressive mCRPC received Dose A of AMG 340 administered as an intravenous (IV) infusion every 3 week (Q3W). |
| OG001 | Cohort 2: Dose B | Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W. |
| OG002 | Cohort 3: Dose C | Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W. |
| OG003 | Cohort 4: Dose D | Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W. |
| OG004 | Cohort 5: Dose E | Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W. |
| OG005 | Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| OG006 | Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| OG007 | Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| OG008 | Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| OG009 | Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
| OG010 | Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. |
|
|
| Primary | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | A DLT was defined as a TEAE that was not unequivocally due to the participant's underlying malignancy or other extraneous cause, and appeared within 21 days from the first dose of AMG 340. AEs considered DLTs were:
| DLT evaluable analysis set: All participants who were evaluable for DLTs. A participants was considered DLT evaluable if the participant completed at least the first full treatment cycle or experienced a DLT during the first treatment cycle. | Posted | Count of Participants | Participants | Up to approximately Day 21 |
|
|
|
| Primary | Median Concentration of AMG 340 | Blood samples for pharmacokinetics (PK) analysis were collected at specific time points. PK parameters were estimated using standard non-compartmental approaches. | PK analysis set: Included all participants who received at least 1 dose of AMG 340 and had at least 1 PK sample drawn post dose. Summary statistics are presented per dose level as pre-specified in SAP Section 9.7. | Posted | Median | Full Range | µg/mL | Cohorts 1-5: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 8, and 10; Cohorts 6-10: Days 1 (pre-dose to 6 hours post-dose), 2, 3, 5 (pre-dose to 6 hours post-dose), 6, 7, 8 (pre-dose to 6 hours post-dose), 9, 10 |
|
|
|
| Secondary | Percentage of Participants Who Achieved an Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | OR was defined as a partial response (PR) or complete response (CR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed PR/CR or did not have any follow-up tumor assessments were regarded as non-responders. | RECIST 1.1 Evaluable Analysis Set: All participants who have received at least 1 dose of AMG 340, had measurable disease per RECIST 1.1 at baseline, and had the opportunity to be followed for at least 6 weeks from start of AMG 340 treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of study Day 1 until death due to any cause. | SAS: All participants who received at least 1 dose of AMG 340. | Posted | Median | Full Range | Months | Up to approximately 24 months |
|
|
|
| Secondary | Prostate Specific Antigen (PSA) Progression Free Survival (PFS) | PSA PFS was defined as the interval from study day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement. If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or unknown, PSA PFS was censored at study day 1. | SAS: All participants who received at least 1 dose of AMG 340. | Posted | Median | Full Range | Months | Up to approximately 24 months |
|
|
|
| Secondary | Radiographic PFS (rPFS) | rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. If a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1. | SAS: All participants who received at least 1 dose of AMG 340. | Posted | Median | Full Range | Months | Up to approximately 24 months |
|
|
|
| Secondary | Percentage of Participants With rPFS at 6 Months | rPFS was defined as the interval from study day 1 to radiographic progression or death from any cause, whichever occurred first, in the absence of subsequent anti-cancer therapy; otherwise, rPFS was censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. If a participant had no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS was censored at study day 1. | SAS: All participants who received at least 1 dose of AMG 340. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
|
| Secondary | Percentage of Participants With a 30% Reduction From Baseline in PSA (PSA30) | PSA 30 was defined as a ≥ 30% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., > 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
|
|
| Secondary | Percentage of Participants With a 50% Reduction From Baseline in PSA (PSA50) | PSA 50 was defined as a ≥ 50% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., > 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
|
|
| Secondary | Percentage of Participants With a 70% Reduction From Baseline in PSA (PSA70) | PSA 70 was defined as a ≥ 70% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., > 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
|
|
| Secondary | Percentage of Participants With a 90% Reduction From Baseline in PSA (PSA90) | PSA 90 was defined as a ≥ 90% reduction from the baseline PSA. This PSA response had to be confirmed by a second consecutive value obtained at least three weeks later. | The PSA response evaluable analysis set was defined as all participants who received at least one dose of AMG 340, had a measurable (i.e., > 0) PSA at baseline, and had the opportunity to be followed for at least nine weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to nine weeks were included in this analysis set if the data snapshot date was at least nine weeks after their first study dose date. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 24 months |
|
|
|
| Secondary | Duration of Response (DOR) Per RECIST 1.1 | DOR was defined as the time from the date of an initial objective response per RECIST 1.1, which was subsequently confirmed, until soft-tissue progression per RECIST 1.1 or death, whichever occurred first in the absence of subsequent anti-cancer therapy. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan prior to subsequent anti-cancer therapy. This endpoint only applied to participants with an objective response (CR or PR) per RECIST 1.1. No participants achieved CR or PR, therefore, no participants could be analyzed for this outcome measure. | RECIST 1.1 Evaluable Analysis Set: All participants who received at least one dose of AMG 340, had measurable disease per RECIST 1.1 at baseline, and had the opportunity to be followed for at least six weeks from the start of AMG 340 treatment. Participants who stopped disease assessments prior to six weeks were included in this analysis set if the data snapshot date was at least six weeks after their first study dose date. | Posted | Up to approximately 24 months |
|
|
| Secondary | Number of Participants With Symptomatic Skeletal Events (SSE) | SSE was defined as time from study day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of AMG 340 or end of safety follow-up date, whichever was later. | SAS: All participants who received at least 1 dose of AMG 340. | Posted | Number | Number of Participants | Up to approximately 24 months |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Cohort 2: Dose B | Participants with progressive mCRPC received Dose B of AMG 340 administered as an IV infusion Q3W. | 1 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Cohort 3: Dose C | Participants with progressive mCRPC received Dose C of AMG 340 administered as an IV infusion Q3W. | 2 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Cohort 4: Dose D | Participants with progressive mCRPC received Dose D of AMG 340 administered as an IV infusion Q3W. | 3 | 5 | 3 | 5 | 5 | 5 |
| EG004 | Cohort 5: Dose E | Participants with progressive mCRPC received Dose E of AMG 340 administered as an IV infusion Q3W. | 4 | 6 | 3 | 6 | 6 | 6 |
| EG005 | Cohort 6a: AMG 340 PmD (High) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. | 4 | 6 | 4 | 6 | 6 | 6 |
| EG006 | Cohort 6b: AMG 340 PmD (Low) and Then AMG 340 Dose E | Participants with progressive mCRPC received AMG 340 PmD (low) on Day 1 followed by AMG 340 Dose E on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. | 2 | 3 | 2 | 3 | 3 | 3 |
| EG007 | Cohort 7a: AMG 340 PmD (High) and Then AMG 340 Dose F | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose F on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. | 2 | 5 | 1 | 5 | 5 | 5 |
| EG008 | Cohort 8a: AMG 340 PmD (High) and Then AMG 340 Dose G | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose G on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. | 2 | 3 | 2 | 3 | 3 | 3 |
| EG009 | Cohort 9: AMG 340 PmD (High) and Then AMG 340 Dose H | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H on Day 8, both administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. | 4 | 7 | 4 | 7 | 7 | 7 |
| EG010 | Cohort 10: AMG 340 PmD (High) and Then AMG 340 Dose H and Dose I | Participants with progressive mCRPC received AMG 340 PmD (high) on Day 1 followed by AMG 340 Dose H and Dose I on Day 8, all doses were administered as IV infusions Q3W in 21-day cycles. Following protocol amendment 5 (07 Dec 2022), a second priming dose was added on Cycle 1 Day 5. | 0 | 2 | 0 | 2 | 2 | 2 |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Bell's palsy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Genital pain | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Ex-tobacco user | Social circumstances | MedDRA 25.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |